# K875048: Sarns Venoatrial Catheter

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Feb 18, 1988 after 71 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964374: Sarns Venous Return Catheters with Duraflo Treatment (1997), 0 descendants of its own

## Recalls of this device
- May 23, 2014 · Class II · Z-2101-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

Source page: https://510kreport.com/device/K875048
Methodology: https://510kreport.com/methodology