K233091
- 510(k) number
- K233091
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
- Applicant
- Qura S.R.L IT
- Product code
- KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Decision date
- 2023-10-26
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233091.pdf
Official FDA record: K233091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.