The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Pureflow Standard Heat Exchanger And Quantum Pureflow Cardioplegia Heat Exchanger.
| Device ID | K220110 |
| 510k Number | K220110 |
| Device Name: | Quantum PureFlow Standard Heat Exchanger And Quantum PureFlow Cardioplegia Heat Exchanger |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Qura S.r.l. Via Di Mezzo, 23 Mirandola, IT 41037 |
| Contact | Raffaella Tommasini |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-13 |
| Decision Date | 2022-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160301003 | K220110 | 000 |
| 18051160302267 | K220110 | 000 |