FDA 510(k)

Biowy PlCC Catheter

Número K: K173956 · 2018-05-21

Data da decisão2018-05-21

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biowy PlCC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K173956. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biowy PlCC Catheter?

Biowy PlCC Catheter is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Biowy Corporation. The 510(k) number is K173956.

When did Biowy PlCC Catheter receive FDA 510(k) clearance?

Biowy PlCC Catheter received FDA 510(k) clearance on 2018-05-21, under 510(k) number K173956.

Who is the listed applicant for Biowy PlCC Catheter?

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

What is the FDA product code for Biowy PlCC Catheter?

The FDA product code for Biowy PlCC Catheter is LJS.

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Outros registros que listam Biowy Corporation como candidato(a)

K233658Biowy Tym Tube (TT)K192246Biowy PICC Catheter S Kit

Dispositivos Relacionados (Código: LJS)

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