FDA 510(k)

Stone Retrieval Balloon Catheter

Número K: K210660 · 2021-04-27

RequerenteAnrei Medical (Hangzhou) Co., Ltd.

Data da decisão2021-04-27

Código do produtoGCA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stone Retrieval Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K210660. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stone Retrieval Balloon Catheter?

Stone Retrieval Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210660.

When did Stone Retrieval Balloon Catheter receive FDA 510(k) clearance?

Stone Retrieval Balloon Catheter received FDA 510(k) clearance on 2021-04-27, under 510(k) number K210660.

Who is the listed applicant for Stone Retrieval Balloon Catheter?

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

What is the FDA product code for Stone Retrieval Balloon Catheter?

The FDA product code for Stone Retrieval Balloon Catheter is GCA.

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Dispositivos Relacionados (Código: GCA)

K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd.K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc.

Fonte oficial

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