K241248 is an FDA 510(k) clearance for the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1). This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on May 31, 2024, 28 days after receiving the submission on May 3, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K241248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2024 |
| Decision Date | May 31, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |