K241206
- 510(k) number
- K241206
- Device name
- Quantum Perfusion Hybrid System
- Applicant
- Spectrum Medical S.R.L. IT
- Product code
- DTN — Reservoir, Blood, Cardiopulmonary Bypass
- Decision date
- 2024-07-18
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241206.pdf
Official FDA record: K241206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.