# K974736: Heartport Direct Aortic Return Cannula with Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jul 15, 1998 after 208 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 5 (0 Class I)
- 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) Heartport® Direct Aortic Return Cannula: named in the summary without a submission number
- (no number) Heartport® Endoarterial Return™ Cannula: named in the summary without a submission number
- (no number) Cardiovascular Research, inc. Cannula Introducer: named in the summary without a submission number

## Recalls of this device
- Oct 2, 2003 · Not classified · Z-0308-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0310-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0307-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0309-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0311-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

## Indications for use
The Direct Aortic Return Cannula is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Direct Aortic Return Cannula also allows the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ catheter. The cannula may be introduced through a 12mm or larger trocar or incision. The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.

Source page: https://510kreport.com/device/K974736
Methodology: https://510kreport.com/methodology