The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Perfusion Arterial Cannula Graft.
| Device ID | K203057 |
| 510k Number | K203057 |
| Device Name: | Quantum Perfusion Arterial Cannula Graft |
| Classification | Catheter, Cannula And Tubing, Vascular, 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 | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-08 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160300839 | K203057 | 000 |