# K182586: DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 19, 2018 after 29 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831591 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831591: Aortic Root Cannula W/Integral Press, Dlp, Inc. (1983) Summary page 4.

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1800-2024: Potential for unsealed sterile packing.
- Mar 19, 2024 · Class II · Z-1801-2024: Potential for unsealed sterile packing.

## Indications for use
The DLP Aortic Root Cannula (Model 23009) is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 23009 cannula may also be used to monitor pressure in the aorta. The DLP Aortic Root Cannula with Vent Line (Model 24009) is intended for use during cardiopulmonary bypass for delivering cardioplegia solutions and venting of the left heart for up to 6 hours. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 24009 cannula may also be used to monitor pressure in the aorta. The DLP Cardioplegia Adapter with Pressure Port (Model 15004) is intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to 6 hours. The DLP Pressure Monitoring Extension Line Adapter (Models 25009 and 25010) is intended for extending the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery up to 6 hours or less.

Source page: https://510kreport.com/device/K182586
Methodology: https://510kreport.com/methodology