The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Perfusion Blood Oxygenator Ecc Vt200-e1, Quantum Perfusion Blood Oxygenator Ecc Vt200-e2, Quantum Perfusion Blood Oxygenator Ecc Vt160-e1, Quantum Perfusion Blood Oxygenator Ecc Vt160-e2.
| Device ID | K203424 |
| 510k Number | K203424 |
| Device Name: | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
| 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 | 2020-11-20 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160300747 | K203424 | 000 |
| 08051160300730 | K203424 | 000 |
| 08051160300686 | K203424 | 000 |
| 08051160300679 | K203424 | 000 |