FDA 510(k)

GORE Molding and Occlusion Balloon Catheter

Número K: K172567 · 2018-01-31

RequerenteW. L. Gore and Associates, Inc.

Data da decisão2018-01-31

Código do produtoMJN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

GORE Molding and Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172567. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K172567.

When did GORE Molding and Occlusion Balloon Catheter receive FDA 510(k) clearance?

GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172567.

Who is the listed applicant for GORE Molding and Occlusion Balloon Catheter?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE Molding and Occlusion Balloon Catheter?

The FDA product code for GORE Molding and Occlusion Balloon Catheter is MJN.

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Outros registros que listam W. L. Gore and Associates, Inc. como candidato(a)

K250410GORE® Tri-Lobe Balloon Catheter K240083GORE® PROPATEN® Vascular Graft K232312GORE® PROPATEN® Vascular Graft K233551GORE® ACUSEAL Vascular Graft K231505GORE® ACUSEAL Vascular Graft K222919GORE® ENFORM Biomaterial

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Dispositivos Relacionados (Código: MJN)

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Fonte oficial

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