510(k) K201320 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Nov 3, 2021 |
| Received | May 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2025 | Spectrum Medical Inc Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors
Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Model/Catalog Number: CP22V-VT
Software Version: N/ Open, Classified |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.