Aperta NSE™ PTA Balloon Dilatation Catheter

Primary DI
04543660025595
Brand
Aperta NSE™ PTA Balloon Dilatation Catheter
Company
GOODMAN CO.,LTD.
Model
AA18-05040040
Catalog number
AA18-05040040
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 = 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.
Published
2024-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232013000Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., Ltd.2024-03-28PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04543660025595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04543660025595045436600255954543660025595

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690965116
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
04543660025601Aperta NSE™ PTA Balloon Dilatation CatheterAA18-05050040AA18-050500402024-08-05
04543660025618Aperta NSE™ PTA Balloon Dilatation CatheterAA18-05060040AA18-050600402024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801057Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-05-15
B090XC2201450XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
B090XC2201451XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
06972253606060PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606084PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606107PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606121PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606145PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606183PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606206PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606220PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606268PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606329PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606343PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606367PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606404PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606428PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606442PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606466PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606480PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253605780PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605797PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605803PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605810PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605827PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605834PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605841PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605858PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605865PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605872PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24