FDA 510(k)

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

Número K: K210996 · 2021-04-23

Data da decisão2021-04-23

Código do produtoNRY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210996. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Imperative Care, Inc.. The 510(k) number is K210996.

When did ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing receive FDA 510(k) clearance?

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210996.

Who is the listed applicant for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

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

What is the FDA product code for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing?

The FDA product code for ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing is NRY.

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Fonte oficial

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