FDA 510(k)

Tri-Ex Extraction Balloon with Multiple Sizing

Número K: K193344 · 2019-12-13

Data da decisão2019-12-13

Código do produtoGCA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tri-Ex Extraction Balloon with Multiple Sizing is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193344. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tri-Ex Extraction Balloon with Multiple Sizing?

Tri-Ex Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K193344.

When did Tri-Ex Extraction Balloon with Multiple Sizing receive FDA 510(k) clearance?

Tri-Ex Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193344.

Who is the listed applicant for Tri-Ex Extraction Balloon with Multiple Sizing?

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

What is the FDA product code for Tri-Ex Extraction Balloon with Multiple Sizing?

The FDA product code for Tri-Ex Extraction Balloon with Multiple Sizing is GCA.

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Fonte oficial

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