# K994171: Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Cardiac Surgical Products
- Decided: Apr 27, 2000 after 139 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic DLP Aortic Root Cannula: named in the summary without a submission number
- (no number) Medtronic DLP Y-Type Coronary Perfusion Adapter: named in the summary without a submission number
- (no number) Medtronic DLP Coronary Cannula: named in the summary without a submission number

## Indications for use
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.

Source page: https://510kreport.com/device/K994171
Methodology: https://510kreport.com/methodology