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Dlp® 80122

by Medtronic, Inc.

Dlp® 80122 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K840002 on 13 Feb 1984 and listed in FDA GUDID since 17 Jun 2016 (UDI-DI 20613994742517), active as of 23 Oct 2026. 3 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

510(k) K840002

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 Number20613994742517 UDI-DI Date17 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK840002 Date13 Feb 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K840002 decided 13 Feb 1984 Active
  • FDA GUDID UDI-DI 20613994742517 listed 17 Jun 2016 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0986-2025 FDA Class II initiated 12 Dec 2024

    Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

    • Ongoing Z-1793-2024 FDA Class II initiated 19 Mar 2024

    Potential for unsealed sterile packing.

    • Terminated Z-1927-2008 FDA Unclassified (pre-2012) initiated 9 May 2008

    Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

Timeline

5 dated events

  1. Cleared FDA 510(k) K840002
  2. Recall initiated FDA recalls Z-1927-2008
  3. Listed FDA GUDID 20613994742517
  4. Recall initiated FDA recalls Z-1793-2024
  5. Recall initiated FDA recalls Z-0986-2025

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  • Withdrawn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
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Model / reference
80122
Primary DI / UDI-DI
20613994742517
510(k) Number
FDA product code
DWF
GMDN term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Device class
Class II
Regulation number
870.4210
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 22.0 French

Related devices

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Cleared under the same submission (K840002)

and 8 more cleared under K840002

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)