# K905224: Cardiopulmonary Bypass Vascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Feb 5, 1991 after 77 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K083301: X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters (2008), 3 descendants of its own
- K132811: Sarns Soft-Flow Extended Aortic Cannula (2014), 0 descendants of its own
- K132451: Sarns Soft-Flow Aortic Cannula (2014), 0 descendants of its own
- K133151: Sarns High Flow Aortic Arch Cannula (2014), 0 descendants of its own
- K964374: Sarns Venous Return Catheters with Duraflo Treatment (1997), 0 descendants of its own

## Recalls of this device
- May 23, 2014 · Class II · Z-2106-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- May 23, 2014 · Class II · Z-2097-2014: 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/K905224
Methodology: https://510kreport.com/methodology