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Dlp® 10012

by Medtronic, Inc.

Dlp 10012 is a cardioplegia cannula (FDA Class II; FDA product code DWF, Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass) made by Medtronic, Inc., cleared under FDA 510(k) K790565 on 11 Jun 1979 and listed in FDA GUDID since 22 May 2016 (UDI-DI 20613994540250), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K790565

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20613994540250 UDI-DI Date22 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK790565 Date11 Jun 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K790565 decided 11 Jun 1979 Active
  • FDA GUDID UDI-DI 20613994540250 listed 22 May 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0289-2025 FDA Class II initiated 3 Oct 2024

    There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Timeline

3 dated events

  1. Cleared FDA 510(k) K790565
  2. Listed FDA GUDID 20613994540250
  3. Recall initiated FDA recalls Z-0289-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dlp®
Generic name
Cardioplegia cannula
Model / reference
10012
Primary DI / UDI-DI
20613994540250
510(k) Number
FDA product code
DWF
GMDN term
Cardioplegia cannula
Device class
Class II
Regulation number
870.4210
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 9.0 French

Related devices

Category: Cardioplegia cannula

Cleared under the same submission (K790565)

and 8 more cleared under K790565

Similar devices

Other devices filed under FDA product code DWF (CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
Other properties (12, all answered No)