# K213540: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: May 20, 2022 after 193 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: 7 generations back to K800178 (1980). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171979: Tubing Pack, Medtronic, Inc. (2017) Summary page 5.

## Indications for use
Quantum SuperPAC Tubing Set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours. Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Source page: https://510kreport.com/device/K213540
Methodology: https://510kreport.com/methodology