The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Superpac Tubing Set, Quantum Superpac Cardioplegia Set.
| Device ID | K213540 |
| 510k Number | K213540 |
| Device Name: | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set |
| 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 | 2021-11-08 |
| Decision Date | 2022-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051160301706 | K213540 | 000 |
| 18051160301987 | K213540 | 000 |
| 18051160301994 | K213540 | 000 |
| 18051160302007 | K213540 | 000 |
| 18051160302014 | K213540 | 000 |
| 18051160302021 | K213540 | 000 |
| 18051160302038 | K213540 | 000 |
| 18051160302045 | K213540 | 000 |
| 08051160301355 | K213540 | 000 |
| 08051160301362 | K213540 | 000 |
| 08051160301379 | K213540 | 000 |
| 08051160301386 | K213540 | 000 |
| 08051160301461 | K213540 | 000 |
| 08051160301492 | K213540 | 000 |
| 08051160301522 | K213540 | 000 |
| 08051160301690 | K213540 | 000 |
| 18051160302717 | K213540 | 000 |