FDA 510(k)

Yikang Latex Foley Catheter

Número K: K173340 · 2018-07-13

RequerenteJiangxi Yikang Medical Instrument Group Co., Ltd.

Data da decisão2018-07-13

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Yikang Latex Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K173340. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Yikang Latex Foley Catheter?

Yikang Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. The 510(k) number is K173340.

When did Yikang Latex Foley Catheter receive FDA 510(k) clearance?

Yikang Latex Foley Catheter received FDA 510(k) clearance on 2018-07-13, under 510(k) number K173340.

Who is the listed applicant for Yikang Latex Foley Catheter?

The FDA 510(k) record lists Jiangxi Yikang Medical Instrument Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yikang Latex Foley Catheter?

The FDA product code for Yikang Latex Foley Catheter is EZL.

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Outros registros que listam Jiangxi Yikang Medical Instrument Group Co., Ltd. como candidato(a)

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