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510(k) Data Aggregation
K Number
K243944Device Name
Aperta NSE PTA Balloon Dilatation Catheter
Manufacturer
Goodman Co., Ltd.
Date Cleared
2025-04-22
(123 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Goodman Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.
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K Number
K232013Device Name
Aperta 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)
Manufacturer
Goodman Co., Ltd.
Date Cleared
2024-03-28
(266 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Goodman Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.
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