# K771499: Flexible Arterial Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Aug 16, 1977 after 11 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 12 (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
- K964373: Sarns Arterial Cannulae with Duraflo Treatment (1997), 0 descendants of its own

## Recalls of this device
- May 23, 2014 · Class II · Z-2095-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- Jan 7, 2013 · Class II · Z-0667-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0668-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0670-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0671-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0666-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0669-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- May 9, 2012 · Class II · Z-1838-2012: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo C
- May 9, 2012 · Class II · Z-1837-2012: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo C
- May 9, 2012 · Class II · Z-1836-2012: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo C
- May 9, 2012 · Class II · Z-1835-2012: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo C
- Sep 12, 2005 · Not classified · Z-0200-06: There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

Source page: https://510kreport.com/device/K771499
Methodology: https://510kreport.com/methodology