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FDA 510(k)

WOLF Thrombectomy System, 6F

K-Number: K210530 · 2021-08-27

ApplicantDevoro Medical, Inc.
Decision Date2021-08-27
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy System, 6F is a medical device manufactured by Devoro Medical, Inc.. It received FDA 510(k) clearance on 2021-08-27 under approval number K210530. 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 System, 6F?

WOLF Thrombectomy System, 6F is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Devoro Medical, Inc.. The 510(k) number is K210530.

When was WOLF Thrombectomy System, 6F approved by the FDA?

WOLF Thrombectomy System, 6F received FDA 510(k) clearance on 2021-08-27, under approval number K210530.

What company makes WOLF Thrombectomy System, 6F?

WOLF Thrombectomy System, 6F is manufactured by Devoro Medical, Inc..

What is the FDA product code for WOLF Thrombectomy System, 6F?

The FDA product code for WOLF Thrombectomy System, 6F is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_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 NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Devoro Medical, Inc.

K200101WOLF Thrombectomy V System K210911WOLF Thrombectomy System, 14F K221391WOLF Thrombectomy™ SmartClaw Catheter 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

View on FDA Database →

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

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