# K955121: Heartport Endoarterial Return Cannual

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: May 10, 1996 after 183 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Bio-Medicus Cannula-Tubing: named in the summary without a submission number
- (no number) Tuohy-Borts Y Hemostasis Valve: named in the summary without a submission number

## Most influential descendants
- K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System (1996), 0 descendants of its own

## 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
Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannufa serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter int6 the femoral artery.

Source page: https://510kreport.com/device/K955121
Methodology: https://510kreport.com/methodology