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Dlp® 20012S

by Medtronic, Inc.

Dlp 20012S 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) K810548 on 17 Mar 1981 and listed in FDA GUDID since 22 May 2016 (UDI-DI 20613994495529), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K810548

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 Number20613994495529 UDI-DI Date22 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK810548 Date17 Mar 1981DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K810548 decided 17 Mar 1981 Active
  • FDA GUDID UDI-DI 20613994495529 listed 22 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K810548
  2. Listed FDA GUDID 20613994495529

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  • Withdrawn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
20012S
Primary DI / UDI-DI
20613994495529
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 (K810548)

and 8 more cleared under K810548

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)