Submission Details
| 510(k) Number | K213540 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
May 2022
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K213540 is an FDA 510(k) clearance for the Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set, 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 review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Manufacturer
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