# K180979: PureFlex Arterial Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 16, 2018 after 217 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 K870825 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162215: Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae, Sorin Group Italia S.R.L. (2017) Summary page 4.

## Indications for use
The Arterial Cannulae are intended to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.

Source page: https://510kreport.com/device/K180979
Methodology: https://510kreport.com/methodology