# K020784: Jostra Single Stage Venous Return Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Jan 9, 2003 after 304 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 Single Stage Venous Cannulae: named in the summary without a submission number

## Indications for use
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.

Source page: https://510kreport.com/device/K020784
Methodology: https://510kreport.com/methodology