# K925442: Sarns Retrograde Cannula

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: May 21, 1993 after 205 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 7, 2004 · Not classified · Z-1351-04: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Jul 7, 2004 · Not classified · Z-1350-04: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Jul 7, 2004 · Not classified · Z-1349-04: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Aug 8, 2003 · Not classified · Z-1193-03: Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Aug 8, 2003 · Not classified · Z-1192-03: Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

Source page: https://510kreport.com/device/K925442
Methodology: https://510kreport.com/methodology