Submission Details
| 510(k) Number | K240908 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2024 |
| Decision Date | July 08, 2025 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
Jul 2025
Decision
462d
Days
Class 2
Risk
About This 510(k) Submission
K240908 is an FDA 510(k) clearance for the Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM), a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on July 8, 2025, 462 days after receiving the submission on April 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.
Device Classification
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4240 |
Manufacturer
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