The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Pureflow Standard Heat Exchanger, Quantum Pureflow Cardioplegia Heat Exchanger.
| Device ID | K212688 |
| 510k Number | K212688 |
| Device Name: | Quantum PureFlow Standard Heat Exchanger, 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 |
| Correspondent | Raffaella Tommasini Qura S.r.l. Via Di Mezzo, 23 Mirandola, IT 41037 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-25 |
| Decision Date | 2022-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160301263 | K212688 | 000 |
| 08051160301188 | K212688 | 000 |
| 08051160301195 | K212688 | 000 |
| 08051160301201 | K212688 | 000 |
| 08051160301218 | K212688 | 000 |
| 08051160301225 | K212688 | 000 |
| 08051160301232 | K212688 | 000 |
| 08051160301249 | K212688 | 000 |
| 08051160301256 | K212688 | 000 |
| 08051160301171 | K212688 | 000 |