FDA 510(k)

Sorin Connect

Número K: K170460 · 2017-06-08

Data da decisão2017-06-08

Código do produtoDXJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sorin Connect is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170460. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sorin Connect?

Sorin Connect is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K170460.

When did Sorin Connect receive FDA 510(k) clearance?

Sorin Connect received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170460.

Who is the listed applicant for Sorin Connect?

The FDA 510(k) record lists Sorin Group Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sorin Connect?

The FDA product code for Sorin Connect is DXJ.

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