# K162215: Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 16, 2017 after 312 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 K870825 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870825: New Model Styles for Aortic Arch Cannula, Shiley, Inc. (1987) Summary page 4.

## Most influential descendants
- K180979: PureFlex Arterial Cannulae (2018), 0 descendants of its own

## Indications for use
Aortic Arch Cannulae: The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours. Optiflow Aortic Arch Cannulae: The device is intended to be used as perfusion cannulae to return arterial blood from the extracorportal circuit to the patient during cardiopulmonary surgery for periods of up to six hours.

Source page: https://510kreport.com/device/K162215
Methodology: https://510kreport.com/methodology