# K014303: Jostra Retrograde Cardioplegia Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AG
- Decided: Mar 26, 2002 after 85 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 Retrograde Cardioplegia Cannula: named in the summary without a submission number

## Indications for use
The Jostra Retrograde Cardioplegia Cannulas are designed for the infusion of blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus system during cardiopulmonary bypass up to 6 hours or less.

Source page: https://510kreport.com/device/K014303
Methodology: https://510kreport.com/methodology