FDA 510(k)

BOSS Balloon Guide Catheter

Número K: K200910 · 2020-05-02

Data da decisão2020-05-02

Código do produtoQJP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

BOSS Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Marblehead Medical. It received FDA 510(k) clearance on 2020-05-02 under 510(k) number K200910. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BOSS Balloon Guide Catheter?

BOSS Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2020-05-02. The listed applicant is Marblehead Medical. The 510(k) number is K200910.

When did BOSS Balloon Guide Catheter receive FDA 510(k) clearance?

BOSS Balloon Guide Catheter received FDA 510(k) clearance on 2020-05-02, under 510(k) number K200910.

Who is the listed applicant for BOSS Balloon Guide Catheter?

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

What is the FDA product code for BOSS Balloon Guide Catheter?

The FDA product code for BOSS Balloon Guide Catheter is QJP.

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