The following data is part of a premarket notification filed by Medtronic Inc with the FDA for Affinity Nt Oxygenator, Affinity Nt Oxygenator With Trillium Biosurface, Affinity Nt Oxygenator With Cortiva Bioactive Surface, Affinity Fusion Oxygenator With Cortiva Bioactive Surface, Affinity Fusion Oxygenator With Balance Biosurface.
| Device ID | K183490 |
| 510k Number | K183490 |
| Device Name: | Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Balance Biosurface |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Medtronic Inc 7611 Northland Dr Minneapolis, MN 55428 |
| Contact | Wendy Pinor |
| Correspondent | Wendy Pinor Medtronic Inc 7611 Northland Dr Minneapolis, MN 55428 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000225476 | K183490 | 000 |
| 00763000225469 | K183490 | 000 |