FDA 510(k)

Shoocin Introducer Kit

Número K: K172099 · 2017-10-05

RequerenteLepu Medical Technology (Beijing) Co., Ltd.

Data da decisão2017-10-05

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Shoocin Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K172099. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Shoocin Introducer Kit?

Shoocin Introducer Kit is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K172099.

When did Shoocin Introducer Kit receive FDA 510(k) clearance?

Shoocin Introducer Kit received FDA 510(k) clearance on 2017-10-05, under 510(k) number K172099.

Who is the listed applicant for Shoocin Introducer Kit?

The FDA 510(k) record lists Lepu Medical Technology (Beijing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shoocin Introducer Kit?

The FDA product code for Shoocin Introducer Kit is DYB.

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Outros registros que listam Lepu Medical Technology (Beijing) Co., Ltd. como candidato(a)

K172331Tipo I, Tipo II, Tipo III, Tipo IV

Dispositivos Relacionados (Código: DYB)

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Fonte oficial

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