Submission Details
| 510(k) Number | K233091 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2023 |
| Decision Date | October 26, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
Oct 2023
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K233091 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT), a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on October 26, 2023, 30 days after receiving the submission on September 26, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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