K240908
- 510(k) number
- K240908
- Device name
- Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- Applicant
- Spectrum Medical , Ltd. GB
- Product code
- DTR — Heat-Exchanger, Cardiopulmonary Bypass
- Decision date
- 2025-07-08
- Date received
- 2024-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240908.pdf
Official FDA record: K240908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.