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WOLF Thrombectomy System, 14F FD0364-03

by Devoro Medical Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850029546030 UDI-DIDate12 Jul 2023ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
WOLF Thrombectomy System, 14F
Generic Name
Thrombectomy suction catheter
Model / Reference
FD0364-03
Primary DI / UDI-DI
00850029546030
FDA Product Code
QEW
GMDN Term
Thrombectomy suction catheter
Device Class
Class II
Regulation Number
870.5150
GUDID distribution status
Not in Commercial Distribution
Size
Length — 60 Centimeter
Outer Diameter — 8 Millimeter

Other devices from Devoro Medical Inc.

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No