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Wire Guide C-SF-15-50

by C2DX, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

9 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850007350321 UDI-DI Date10 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · 9 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-1833-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1828-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1825-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1842-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1845-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1827-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1834-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1832-2022 FDA Class II initiated 16 Aug 2022
    • Ongoing Z-1836-2022 FDA Class II initiated 16 Aug 2022

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Wire Guide
Generic Name
Peripheral vascular guidewire, manual
Model / Reference
C-SF-15-50
Primary DI / UDI-DI
00850007350321
510(k) Number
FDA Product Code
DQX
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class II
Regulation Number
870.1330
GUDID distribution status
In Commercial Distribution

Other devices from C2DX, Inc.

See all devices from C2DX, 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