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FDA 510(k)

ClotTriever Thrombectomy System

K-Number: K210190 · 2021-02-23

ApplicantIrani Medical, Inc.
Decision Date2021-02-23
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClotTriever Thrombectomy System is a medical device manufactured by Irani Medical, Inc.. It received FDA 510(k) clearance on 2021-02-23 under approval number K210190. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClotTriever Thrombectomy System?

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

When was ClotTriever Thrombectomy System approved by the FDA?

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

What company makes ClotTriever Thrombectomy System?

ClotTriever Thrombectomy System is manufactured by Irani Medical, Inc..

What is the FDA product code for ClotTriever Thrombectomy System?

The FDA product code for ClotTriever Thrombectomy System is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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