Submission Details
| 510(k) Number | K241206 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2024 |
| Decision Date | July 18, 2024 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Perfusion Hybrid System
Jul 2024
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K241206 is an FDA 510(k) clearance for the Quantum Perfusion Hybrid System, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on July 18, 2024, 79 days after receiving the submission on April 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.
Device Classification
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4400 |
Manufacturer
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