# K920902: Modification of Sarns Two Stage Venous Cannula

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: May 11, 1993 after 440 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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

## Recalls of this device
- May 23, 2014 · Class II · Z-2102-2014: 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-2100-2014: 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-2096-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- Mar 3, 2014 · Class II · Z-1224-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1220-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1223-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1222-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1221-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1219-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag
- Mar 3, 2014 · Class II · Z-1218-2014: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stag

Source page: https://510kreport.com/device/K920902
Methodology: https://510kreport.com/methodology