Dlp 25010: EU MDD Class IIa registered 2026, Medtronic, Inc.

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-20613994918585 Basic UDI-DI 20613994918585UDI-DI	Date6 Nov 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK182586	Date19 Oct 2018Decided	StatusActive
United States	GUDID listing GUDID	Number20613994918585 UDI-DI	Date22 May 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK831591	Date30 Jun 1983Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-20613994918585 — open Devices and search for it
AccessGUDID record UDI-DI 20613994918585
FDA 510(k) database 510(k) number K182586
FDA 510(k) database 510(k) number K831591

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-20613994918585 registered 6 Nov 2026 Active
FDA 510(k) K182586 decided 19 Oct 2018 Active· +1 more in the status table
FDA GUDID UDI-DI 20613994918585 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

8 dated events

30 Jun 1983 Cleared FDA 510(k) K831591
22 May 2016 Listed FDA GUDID 20613994918585
22 Jun 2017 Recall initiated FDA recalls Z-2766-2017
22 Jun 2017 Recall initiated FDA recalls Z-2767-2017
19 Oct 2018 Cleared FDA 510(k) K182586
19 Mar 2024 Recall initiated FDA recalls Z-1801-2024
19 Mar 2024 Recall initiated FDA recalls Z-1800-2024
6 Nov 2026 Registered EUDAMED B-20613994918585

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Dlp®
Generic name: Cardioplegia solution administration adaptor
Device name: DLP Pressure Monitoring Ext Line Adapter
Model / reference: 25010

Primary DI / UDI-DI: 20613994918585
Basic UDI-DI: B-20613994918585
510(k) Number: K182586
K831591
FDA product code: DWF
EMDN code: C0301040499 Cardioplegia cannulas - other
GMDN term: Cardioplegia solution administration adaptor

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 870.4210
EU registration type: Legacy device (under a directive)
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Size: Length — 1.8 Meter

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.