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WOLF Thrombectomy™ SmartClaw Catheter

by Devoro Medical Inc. 510(k)

Active United States

510(k) K221391

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221391 Date10 Nov 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QEW
FDA applicant
Devoro Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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