FDA 510(k)

CAPERE Thrombectomy System

Número K: K180722 · 2018-06-11

Data da decisão2018-06-11

Código do produtoQEW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CAPERE Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Kp Medcure, Inc.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K180722. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CAPERE Thrombectomy System?

CAPERE Thrombectomy System is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Kp Medcure, Inc.. The 510(k) number is K180722.

When did CAPERE Thrombectomy System receive FDA 510(k) clearance?

CAPERE Thrombectomy System received FDA 510(k) clearance on 2018-06-11, under 510(k) number K180722.

Who is the listed applicant for CAPERE Thrombectomy System?

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

What is the FDA product code for CAPERE Thrombectomy System?

The FDA product code for CAPERE Thrombectomy System is QEW.

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