FDA 510(k)

Straub Endovascular System

Número K: K172315 · 2018-04-12

Data da decisão2018-04-12

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Straub Endovascular System is the device name listed in this FDA 510(k) record. The listed applicant is Straub Medical AG. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K172315. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Straub Endovascular System?

Straub Endovascular System is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Straub Medical AG. The 510(k) number is K172315.

When did Straub Endovascular System receive FDA 510(k) clearance?

Straub Endovascular System received FDA 510(k) clearance on 2018-04-12, under 510(k) number K172315.

Who is the listed applicant for Straub Endovascular System?

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

What is the FDA product code for Straub Endovascular System?

The FDA product code for Straub Endovascular System is MCW.

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