Skip to content

Dlp® 15004

by Medtronic, Inc.

Dlp 15004 is a cardioplegia solution administration adaptor (FDA Class II; FDA product code DWF, Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass) made by Medtronic, Inc., cleared under FDA 510(k) K182586 on 19 Oct 2018 (1 earlier submission) and listed in FDA GUDID since 22 May 2016 (UDI-DI 20613994900412), active as of 23 Oct 2026. 4 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK182586 Date19 Oct 2018DecidedStatusActive
United StatesGUDID listing Number20613994900412 UDI-DI Date22 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182586 decided 19 Oct 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 20613994900412 listed 22 May 2016 Listed

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1801-2024 FDA Class II initiated 19 Mar 2024
    • Ongoing Z-1800-2024 FDA Class II initiated 19 Mar 2024

    Potential for unsealed sterile packing.

  • 2 recalls, same reason

    • Terminated Z-2766-2017 FDA Class II initiated 22 Jun 2017
    • Terminated Z-2767-2017 FDA Class II initiated 22 Jun 2017

    Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Timeline

7 dated events

  1. Cleared FDA 510(k) K831591
  2. Listed FDA GUDID 20613994900412
  3. Recall initiated FDA recalls Z-2766-2017
  4. Recall initiated FDA recalls Z-2767-2017
  5. Cleared FDA 510(k) K182586
  6. Recall initiated FDA recalls Z-1801-2024
  7. Recall initiated FDA recalls Z-1800-2024

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  • Withdrawn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 solution administration adaptor
Model / reference
15004
Primary DI / UDI-DI
20613994900412
510(k) Number
FDA product code
DWF
GMDN term
Cardioplegia solution administration adaptor
Device class
Class II
Regulation number
870.4210
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardioplegia solution administration adaptor

Cleared under the same submission (K182586)

Cleared under the same submission (K831591)

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)