FDA 510(k)

Wallaby Avenir Coil System

Número K: K173711 · 2018-05-04

Data da decisão2018-05-04

Código do produtoHCG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wallaby Avenir Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical, Inc.. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173711. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wallaby Avenir Coil System?

Wallaby Avenir Coil System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Wallaby Medical, Inc.. The 510(k) number is K173711.

When did Wallaby Avenir Coil System receive FDA 510(k) clearance?

Wallaby Avenir Coil System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173711.

Who is the listed applicant for Wallaby Avenir Coil System?

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

What is the FDA product code for Wallaby Avenir Coil System?

The FDA product code for Wallaby Avenir Coil System is HCG.

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Dispositivos Relacionados (Código: HCG)

Fonte oficial

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