FDA 510(k)

Stone Retrieval Balloon

Número K: K200173 · 2020-05-01

RequerenteHangzhou AGS MedTech Co., Ltd.

Data da decisão2020-05-01

Código do produtoGCA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stone Retrieval Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K200173. 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?

Stone Retrieval Balloon is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K200173.

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

Stone Retrieval Balloon received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200173.

Who is the listed applicant for Stone Retrieval Balloon?

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

What is the FDA product code for Stone Retrieval Balloon?

The FDA product code for Stone Retrieval Balloon 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 K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) 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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