# K964373: Sarns Arterial Cannulae with Duraflo Treatment

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Jun 18, 1997 after 229 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: 1 generation back to K770429 (1977). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934127: Sarns Low Jetting Aortic Arch Cannula, 3M Health Care, Sarns (1994) Summary page 4.
- K874896: Sarns Visiflow Aortic Arch Cannula, 3M Health Care, Sarns (1988) Summary page 4.
- K834134: Sarns 8.0 Soft Arc Cannula, 3M Health Care, Sarns (1984) Summary page 4.
- K771499: Flexible Arterial Cannulae, 3M Health Care, Sarns (1977) Summary page 4.
- K770429: Cannulae, Aortic, Arch, High Flow, 3M Health Care, Sarns (1977) Summary page 4.
- (no number) Sarns Aortic Arch and Flexible Aortic Arch Cannulae: named in the summary without a submission number

## Indications for use
The Sarns Aortic Arch Cannulae with Duraflo Treatment, Flexible Arterial Cannulae with Duraflo Treatment, High Flow Aortic Arch Cannulae with Duraflo Treatment, Soft Arc Cannula with Duraflo Treatment, D4 Cannulae with Duraflo Treatment, and the Soft Flow Cannulae with Duraflo Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The Sarns Flexible Aortic Arch Cannula with Duraflo Treatment is indicated for use in perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K964373
Methodology: https://510kreport.com/methodology