FDA 510(k)

Kalera Vacuum Aspiration Catheter (K-VAC)

Número K: K200419 · 2020-05-22

Data da decisão2020-05-22

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kalera Vacuum Aspiration Catheter (K-VAC) is the device name listed in this FDA 510(k) record. The listed applicant is Kalera Medical, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K200419. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kalera Vacuum Aspiration Catheter (K-VAC)?

Kalera Vacuum Aspiration Catheter (K-VAC) is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Kalera Medical, Inc.. The 510(k) number is K200419.

When did Kalera Vacuum Aspiration Catheter (K-VAC) receive FDA 510(k) clearance?

Kalera Vacuum Aspiration Catheter (K-VAC) received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200419.

Who is the listed applicant for Kalera Vacuum Aspiration Catheter (K-VAC)?

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

What is the FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC)?

The FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC) is FED.

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