FDA 510(k)

WOLF Thrombectomy SmartClaw Catheter

K-Number: K221391 · 2022-11-10

Decision Date2022-11-10

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy SmartClaw Catheter is a medical device manufactured by Devoro Medical, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval number K221391. 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 WOLF Thrombectomy SmartClaw Catheter?

WOLF Thrombectomy SmartClaw Catheter is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Devoro Medical, Inc.. The 510(k) number is K221391.

When was WOLF Thrombectomy SmartClaw Catheter approved by the FDA?

WOLF Thrombectomy SmartClaw Catheter received FDA 510(k) clearance on 2022-11-10, under approval number K221391.

What company makes WOLF Thrombectomy SmartClaw Catheter?

WOLF Thrombectomy SmartClaw Catheter is manufactured by Devoro Medical, Inc..

What is the FDA product code for WOLF Thrombectomy SmartClaw Catheter?

The FDA product code for WOLF Thrombectomy SmartClaw Catheter is QEW.

Related Clinical Trials

NCT06394739 RevCore for In Stent Thrombosis RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Other Devices by Devoro Medical, Inc.

K200101WOLF Thrombectomy V System K210911WOLF Thrombectomy System, 14F K210530WOLF Thrombectomy System, 6F K241207SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)

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.