The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Perfusion Blood Oxygenator With Integrated Af And Sensor Vt200-c1u, Quantum Perfusion Blood Oxygenator With Integrated Af Vt200-c2u, Quantum Perfusion Blood Oxygenator With Integrated Af And Sensor Vt160-c1u,quantum Perfusion Blood Oxygenator.
| Device ID | K212341 |
| 510k Number | K212341 |
| Device Name: | Quantum Perfusion Blood Oxygenator With Integrated AF And Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator With Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator With Integrated AF And Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-28 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160301454 | K212341 | 000 |
| 08051160301447 | K212341 | 000 |
| 08051160301430 | K212341 | 000 |
| 08051160301423 | K212341 | 000 |