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FDA 510(k)

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

Número K: K243704 · 2025-02-27

RequerenteBrosmed Medical Co., Ltd.
Data da decisão2025-02-27
Código do produtoLIT
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA 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 2025-02-27 under 510(k) number K243704. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter?

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K243704.

When did Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-02-27, under 510(k) number K243704.

Who is the listed applicant for Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA 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 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter?

The FDA product code for Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter is LIT.

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Dispositivos Relacionados (Código: LIT)

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Fonte oficial

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