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Dlp™ CB57417

by Medtronic, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169697560 UDI-DI Date4 Mar 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1914-2015 FDA Class II initiated 12 Jun 2015

    Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dlp™
Generic Name
Cardiopulmonary bypass cannula, femoral
Model / Reference
CB57417
Primary DI / UDI-DI
00643169697560
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass cannula, femoral
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
Not in Commercial Distribution
Size
Catheter Gauge — 17.0 French

Related devices

Cleared under the same submission (K875353)

Show all (9)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Combination Product
  • Lot / Batch Number

Other properties (10)

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