NIPRO VASCULAR CORPORATION Fujigaoka Building

Matched from indexed company URL: NIPRO VASCULAR CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1000533027	1000533027	NIPRO VASCULAR CORPORATION Fujigaoka Building	1	N	2026-01-01	108 Fujigaoka Meito-ku Nagoya Aichi JP 465-0032
3003524171	3003524171	Nipro Vascular Innovations Americas, Inc.	1	N	2026-01-01	870 Hermosa Dr SUNNYVALE CA US 94085
3011826338	3011826338	NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center	1	N	2026-01-01	276-1 Idogane-cho Seto Aichi JP 489-0976
3015551113	3015551113	Nipro Vascular Innovations Americas, Inc.	1	Y	2026-01-01	28 Crosby Drive, Suite 100 Bedford MA US 01730
3030042169	3030042169	NIPRO VASCULAR CORPORATION Aichi Facility	1	N	2026-01-01	1-176 Shiokusagaoka Seto Aichi JP 489-0899

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
04543660026363	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026370	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026387	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026394	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026400	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026417	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026424	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com
04543660026431	Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.	800-596-3104	regulatoryNVIA@nipromed.com

nipromed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
340490	1675915674	K243944	Aperta NSE PTA Balloon Dilatation Catheter	PNO	2025-04-22
340494	1675915674	K243944	Aperta NSE PTA Balloon Dilatation Catheter	PNO	2025-04-22
340496	1675915674	K243944	Aperta NSE PTA Balloon Dilatation Catheter	PNO	2025-04-22
233071	1973671864	K241576	Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )	OGZ	2025-02-26
58067	1973444914	K170987	Captus Vascular Retrieval System	MMX	2017-08-28
233071	1971874102	K163345	TVC Imaging System, TVC Catheter	OGZ	2017-06-21
340490	1121871919
340494	1121871919
58067	1182174753
340490	1833740132
340494	1833740132

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PNO	3	2025-04-22
OGZ	2	2025-02-26
MMX	1	2017-08-28

GUDID#

Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 150mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 100mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 150mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2025-05-12
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-08-05
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-08-05
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-08-05
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 7.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-08-05
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 8.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-08-05
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 7.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 8.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 5.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 7.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 8.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 5.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 7.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
Aperta NSE™ PTA Balloon Dilatation Catheter - The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 8.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
NIPRO VASCULAR CORPORATION
2024-05-03
TVC Integrated Imaging System™ - TThe TVC Integrated Imaging System™ (TVC-MC9i) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. This model of TVC Imaging System is designed to be installed in the catheterization laboratory and minimize usage of space. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32). Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Nipro Vascular Innovations Americas, Inc.
2017-01-27
Makoto Intravascular Imaging System™ - The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural assessment of coronary and peripheral arteries and plaques by using integrated Extended Bandwidth IVUS imaging and chemical assessment of coronary arteries and plaques using NIRS (near infrared spectroscopy) to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42) and the Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42). Indications for Use:1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. 2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Nipro Vascular Innovations Americas, Inc.
2018-07-11

61 records. Showing 1-40. Next