FDA 510(k)

Tri-Wedge PTA Scoring Balloon Dilatation Catheter

Número K: K241478 · 2024-10-22

Data da decisão2024-10-22

Código do produtoPNO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K241478. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K241478.

When did Tri-Wedge PTA Scoring Balloon Dilatation Catheter receive FDA 510(k) clearance?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-10-22, under 510(k) number K241478.

Who is the listed applicant for Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

The FDA 510(k) record lists Brosmed Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

The FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter is PNO.

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Outros registros que listam Brosmed Medical Co., Ltd. como candidato(a)

K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter K212215Tiche PTA Balloon Dilatation Catheter K203390Artimes pro Balloon Dilatation Catheter K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter K153742Catheter de Dilatação Balão Apollo

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: PNO)

K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Cateter de Dilatação Balão PTA NSE ApertaGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC K232013Catheter de Dilatação Balão PTA NSE Aperta (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.

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