# K981995: Quickdraw Venous Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Apr 20, 1999 after 316 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (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 Endovenous Drainage™ Cannula: named in the summary without a submission number
- (no number) RMI Venous Drainage Cannula: named in the summary without a submission number
- (no number) Heartport Endoarterial Return™ Cannula: named in the summary without a submission number

## Recalls of this device
- Nov 27, 2019 · Class II · Z-0800-2020: If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its conn
- May 14, 2013 · Class II · Z-1542-2013: Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

## Indications for use
The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K981995
Methodology: https://510kreport.com/methodology