K250326
- 510(k) number
- K250326
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- Applicant
- Spectrum Medical S.R.L. IT
- Product code
- KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Decision date
- 2025-06-24
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250326.pdf
Official FDA record: K250326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.