# K990772: Directflow Arterial Cannula

- Pathway: 510(k) (Special)
- Applicant: Heartport, Inc.
- Decided: Mar 23, 1999 after 14 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 6 (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) DirectFlow arterial cannula: named in the summary without a submission number

## Recalls of this device
- Apr 27, 2006 · Not classified · Z-1101-06: During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
- 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 DirectFlow™ arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of vascuiar catheters such as the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.

Source page: https://510kreport.com/device/K990772
Methodology: https://510kreport.com/methodology