Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)— 510(k) K240908
Substantially EquivalentSpectrum Medical , Ltd.
FDA 510(k) clearance K240908 for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM), Substantially Equivalent on 2025-07-08. Applicant: Spectrum Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical , Ltd.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gloucester, GB
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More clearances from Spectrum Medical , Ltd.
view allAdverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.