FDA 510(k)

VORTEK URETERAL DOUBLE LOOP STENT

Número K: K180057 · 2018-03-09

Data da decisão2018-03-09

Código do produtoFAD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VORTEK URETERAL DOUBLE LOOP STENT is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2018-03-09 under 510(k) number K180057. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VORTEK URETERAL DOUBLE LOOP STENT?

VORTEK URETERAL DOUBLE LOOP STENT is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Coloplast Corp.. The 510(k) number is K180057.

When did VORTEK URETERAL DOUBLE LOOP STENT receive FDA 510(k) clearance?

VORTEK URETERAL DOUBLE LOOP STENT received FDA 510(k) clearance on 2018-03-09, under 510(k) number K180057.

Who is the listed applicant for VORTEK URETERAL DOUBLE LOOP STENT?

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

What is the FDA product code for VORTEK URETERAL DOUBLE LOOP STENT?

The FDA product code for VORTEK URETERAL DOUBLE LOOP STENT is FAD.

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