The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nt Oxygenator With Balance Biosurface, Affinity Nt Oxygenator With Balance Biosurface And Uncoated Cardiotomy/venous Reservoir.
| Device ID | K191444 |
| 510k Number | K191444 |
| Device Name: | Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous Reservoir |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Harsh Dharamshi |
| Correspondent | Harsh Dharamshi 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 | 2019-05-31 |
| Decision Date | 2019-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000187846 | K191444 | 000 |