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 Carmeda Biosurface.
| Device ID | K143073 |
| 510k Number | K143073 |
| Device Name: | Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Carmeda Biosurface |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry Medtronic, Inc. 7611 Northland Drive 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 | 2014-10-27 |
| Decision Date | 2015-03-25 |
| Summary: | summary |