# Dlp® 25010

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/dlp-r-25010>
- Manufacturer: [Medtronic, Inc.](https://devicerts.com/manufacturers/medtronic-inc) (United States)
- Name in the registry: DLP® 25010
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: DWF
- EMDN: C0301040499 CARDIOPLEGIA CANNULAS - OTHER
- GMDN: Cardioplegia solution administration adaptor (58824)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-20613994918585 · UDI-DI 20613994918585 · registered 2026-11-06 · status: Active
- **GUDID** · FDA 510(k) · United States · K182586 · decision 2018-10-19 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 20613994918585 · listed 2016-05-22 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K831591 · decision 1983-06-30 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1801-2024 · Class II · ongoing · initiated 2024-03-19: Potential for unsealed sterile packing.
- Z-1800-2024 · Class II · ongoing · initiated 2024-03-19: Potential for unsealed sterile packing.
- Z-2766-2017 · Class II · terminated · initiated 2017-06-22: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
- Z-2767-2017 · Class II · terminated · initiated 2017-06-22: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

## Identity

- Trade name: DLP® [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Cardioplegia solution administration adaptor [FDA GUDID (AccessGUDID)]
- Device name: DLP Pressure Monitoring Ext Line Adapter [EUDAMED]
- Model / reference: 25010 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 20613994918585 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-20613994918585 [EUDAMED]
- 510(k) Number: K182586 [FDA GUDID (AccessGUDID)]; K831591 [FDA GUDID (AccessGUDID)]
- FDA product code: DWF [FDA GUDID (AccessGUDID)]
- EMDN code: C0301040499 [EUDAMED]
- GMDN term: Cardioplegia solution administration adaptor (58824) [FDA GUDID (AccessGUDID)]

## Classification

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

## Dimensions & Sizes

- Size: Length — 1.8 Meter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Dlp® 25010, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/dlp-r-25010 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/dlp-r-25010.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/dlp-r-25010
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.