The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Perfusion Single Lumen Cannula 22f, Quantum Perfusion Dual Lumen Cannula 31f, Quantum Perfusion Dual Lumen Cannula 27f, Quantum Perfusion Dual Lumen Cannula 24f.
| Device ID | K203067 |
| 510k Number | K203067 |
| Device Name: | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F |
| 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 | 2020-10-09 |
| Decision Date | 2021-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160300822 | K203067 | 000 |
| 08051160300815 | K203067 | 000 |
| 08051160300808 | K203067 | 000 |
| 08051160300792 | K203067 | 000 |