# K983791: Peripheral Retrograde Cardiaplegia Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Jun 11, 1999 after 227 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
Longest line of descent: 1 generation back to K880103 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880103: Catheter, Cannula and Tubing, Vascular, Cardiopul., Research Medical, Inc. (1988) Summary page 1.

## Cited in the summary but kept off the family tree
- K061270: Heartport Endosinus Catheter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of biood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.

Source page: https://510kreport.com/device/K983791
Methodology: https://510kreport.com/methodology