# K203057: Quantum Perfusion Arterial Cannula Graft

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Jun 30, 2021 after 265 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 K934127 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081560: Vascutek Cannula Graft, Model CGS2008S, Vascutek, Ltd. (2009) Summary page 4.

## Indications for use
The Quantum Perfusion Arterial Cannula Graft is designed to infuse blood to the patient through an arterial vessel during cardiopulmonary bypass procedures for periods of maximum 6 hours. The device is equipped with an additional valved access which allows accessing arterial circulation.

Source page: https://510kreport.com/device/K203057
Methodology: https://510kreport.com/methodology