# K964195: Chase Two Stage Venous Return Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Mar 19, 1997 after 149 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 K770431 (1977). 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)
- K770431: Catheter, Two Stage Venous Return, 3M Health Care, Sarns (1977) Summary page 1.

## Indications for use
The CHASE Two Stage Venous Return Catheter is indicated for single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery.

Source page: https://510kreport.com/device/K964195
Methodology: https://510kreport.com/methodology