FDA 510(k)

ClotTriever Thrombectomy System

Numéro K : K210190 · 2021-02-23

Date de décision2021-02-23

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ClotTriever Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Irani Medical, Inc.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K210190. 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 ClotTriever Thrombectomy System?

ClotTriever Thrombectomy System is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Irani Medical, Inc.. The 510(k) number is K210190.

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

ClotTriever Thrombectomy System received FDA 510(k) clearance on 2021-02-23, under 510(k) number K210190.

Who is the listed applicant for ClotTriever Thrombectomy System?

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

What is the FDA product code for ClotTriever Thrombectomy System?

The FDA product code for ClotTriever 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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