# K972503: Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 26, 1997 after 54 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790564 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896778: Rmi Vasoplegia Cannula with & Without Check Valve, Research Medical, Inc. (1990) Summary page 1.
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 1.
- K791498: Adapter-Y Type/Coronary Perfusion, Dlp, Inc. (1979) Summary page 1.
- K790564: Adapter-Straight, Dlp, Inc. (1979) Summary page 1.
- K790563: Adapters-Y-Type, Dlp, Inc. (1979) Summary page 1.

## Recalls of this device
- Aug 12, 2016 · Class II · Z-2757-2016: The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

## Indications for use
The vessel cannula will be supplied with a wing or without a wing with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery. The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of the cardiopulmonary bypass surgery. The aortic root cannula with vent line is designed to deliver cardioplegia solution and vent the heart during cardiopulmonary bypass surgery. The cardioplegia "Y" perfusion adapter is designed for use with the aortic root cannula and vessel cannula to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia "Y" recirculation adapter is designed for use for recirculating of cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia straight adapter is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. The cardioplegia "Y" venting adapter is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the left heart.

Source page: https://510kreport.com/device/K972503
Methodology: https://510kreport.com/methodology