FDA 510(k)

Capiflo 5001

Número K: K222158 · 2023-01-20

Data da decisão2023-01-20

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Capiflo 5001 is the device name listed in this FDA 510(k) record. The listed applicant is K&L Distributing, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222158. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Capiflo 5001?

Capiflo 5001 is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is K&L Distributing, Inc.. The 510(k) number is K222158.

When did Capiflo 5001 receive FDA 510(k) clearance?

Capiflo 5001 received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222158.

Who is the listed applicant for Capiflo 5001?

The FDA 510(k) record lists K&L Distributing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capiflo 5001?

The FDA product code for Capiflo 5001 is JOW.

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