The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Pureflow Centrifugal Blood Pump Cp22 With Integrated Sensor.
| Device ID | K201320 |
| 510k Number | K201320 |
| Device Name: | Quantum PureFlow Centrifugal Blood Pump CP22 With Integrated Sensor |
| 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 | 2020-05-18 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160300624 | K201320 | 000 |