# K133151: Sarns High Flow Aortic Arch Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Feb 3, 2014 after 109 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770429 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770429: Cannulae, Aortic, Arch, High Flow, 3M Health Care, Sarns (1977) Summary page 1.
- K083301: X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters, Terumo Cardiovascular Systems Corp. (2008) Summary page 1.

## Indications for use
The device is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to six hours of use.

Source page: https://510kreport.com/device/K133151
Methodology: https://510kreport.com/methodology