K213540 is an FDA 510(k) clearance for the Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on May 20, 2022, 193 days after receiving the submission on November 8, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K213540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2021 |
| Decision Date | May 20, 2022 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF - Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |