Submission Details
| 510(k) Number | K203057 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2020 |
| Decision Date | June 30, 2021 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Perfusion Arterial Cannula Graft
Jun 2021
Decision
265d
Days
Class 2
Risk
About This 510(k) Submission
K203057 is an FDA 510(k) clearance for the Quantum Perfusion Arterial Cannula Graft, 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 June 30, 2021, 265 days after receiving the submission on October 8, 2020. 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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