# K964374: Sarns Venous Return Catheters with Duraflo Treatment

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Jun 18, 1997 after 229 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905224: Cardiopulmonary Bypass Vascular Catheter, 3M Health Care, Sarns (1991) Summary page 1.
- K875048: Sarns Venoatrial Catheter, 3M Health Care, Sarns (1988) Summary page 1.
- K810415: Sarns Two-State Wire Reinforced Catheter, 3M Health Care, Sarns (1981) Summary page 1.
- K790246: Sarns Wire-Reinforced Venous Return Can, 3M Health Care, Sarns (1979) Summary page 1.
- K770431: Catheter, Two Stage Venous Return, 3M Health Care, Sarns (1977) Summary page 1.
- (no number) 32, 26, 40 and 51 Fr. Venous Return Catheters: named in the summary without a submission number

## Indications for use
The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery. The Sarns Two Stage Venous Return Catheters with Duraflo Treatment, Venoatrial Catheters with Duraflo Treatment, and the Dual Stage Venous Return Catheters with Duraflo Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K964374
Methodology: https://510kreport.com/methodology