The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Pureflow Centrifugal Blood Pump Cp37, Quantum Pureflow Centrifugal Blood Pump Cp22.
| Device ID | K192850 |
| 510k Number | K192850 |
| Device Name: | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | Qura S.r.l. Via Di Mezzo, 23 Mirandola, IT 41037 |
| Contact | Raffaella Tommasini |
| Correspondent | Raffaella Tommasini Qura S.r.l. Via Di Mezzo, 23 Mirandola, IT 41037 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-03 |
| Decision Date | 2020-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434421838 | K192850 | 000 |
| 05060434421821 | K192850 | 000 |
| 28051160300611 | K192850 | 000 |
| 28051160300604 | K192850 | 000 |
| 05060434422149 | K192850 | 000 |
| 05060434422132 | K192850 | 000 |