FDA 510(k)

ExsoMed ArcPhix and ExsoMed ArrowPhix

Número K: K171407 · 2017-08-18

Data da decisão2017-08-18

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ExsoMed ArcPhix and ExsoMed ArrowPhix is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Holding Company, LLC. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171407. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ExsoMed ArcPhix and ExsoMed ArrowPhix?

ExsoMed ArcPhix and ExsoMed ArrowPhix is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Exsomed Holding Company, LLC. The 510(k) number is K171407.

When did ExsoMed ArcPhix and ExsoMed ArrowPhix receive FDA 510(k) clearance?

ExsoMed ArcPhix and ExsoMed ArrowPhix received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171407.

Who is the listed applicant for ExsoMed ArcPhix and ExsoMed ArrowPhix?

The FDA 510(k) record lists Exsomed Holding Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix?

The FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix is HWC. This falls under the Cardiovascular category.

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