FDA 510(k)

Helo Thrombectomy System

Numéro K : K252956 · 2025-12-18

Date de décision2025-12-18

Code produitQEW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Helo Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Endovascular Engineering, Inc.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252956. 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 Helo Thrombectomy System?

Helo Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Endovascular Engineering, Inc.. The 510(k) number is K252956.

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

Helo Thrombectomy System received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252956.

Who is the listed applicant for Helo Thrombectomy System?

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

What is the FDA product code for Helo Thrombectomy System?

The FDA product code for Helo 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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