Aperta NSE™ PTA Balloon Dilatation Catheter

Primary DI
04543660025748
Brand
Aperta NSE™ PTA Balloon Dilatation Catheter
Company
NIPRO VASCULAR CORPORATION
Model
AW18-09040040
Catalog number
AW18-09040040
Device description
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.
Published
2024-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04543660025748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04543660025748045436600257484543660025748

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
800-596-3104regulatoryNVIA@nipromed.com

Regulatory Flags#

DUNS number
690965116
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04543660026363Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09040100LW18-090401002025-05-12
04543660026370Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09040150LW18-090401502025-05-12
04543660026387Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09050100LW18-090501002025-05-12
04543660026394Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09050150LW18-090501502025-05-12
04543660026400Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09060100LW18-090601002025-05-12
04543660026417Aperta NSE™ PTA Balloon Dilatation CatheterLW18-09060150LW18-090601502025-05-12
04543660026424Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14540100LW18-145401002025-05-12
04543660026431Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14540150LW18-145401502025-05-12
04543660026448Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14550100LW18-145501002025-05-12
04543660026455Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14550150LW18-145501502025-05-12
04543660026462Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14560100LW18-145601002025-05-12
04543660026479Aperta NSE™ PTA Balloon Dilatation CatheterLW18-14560150LW18-145601502025-05-12
04543660026486Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05040100LA18-050401002025-05-12
04543660026493Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05040150LA18-050401502025-05-12
04543660026509Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05050100LA18-050501002025-05-12
04543660026516Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05050150LA18-050501502025-05-12
04543660026523Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05060100LA18-050601002025-05-12
04543660026530Aperta NSE™ PTA Balloon Dilatation CatheterLA18-05060150LA18-050601502025-05-12
04543660025595Aperta NSE™ PTA Balloon Dilatation CatheterAA18-05040040AA18-050400402024-08-05
04543660025601Aperta NSE™ PTA Balloon Dilatation CatheterAA18-05050040AA18-050500402024-08-05

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Primary DI, Brand, Company table
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