FDA 510(k)

CAPERE Thrombectomy System

Numéro K : K180722 · 2018-06-11

Date de décision2018-06-11

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : QEW)

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

Source officielle

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