The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Fusion Oxygenator With Balance Biosurface, Affinity Fusion Oxygenator With Cardiotomy/venous Reservoir And Balance Biosurface, Affinity Fusion Oxygenator With Cortiva Biosurface, Affinity Fusion Oxygenator With Cortiva Bioactive Surface & Ca.
| Device ID | K172626 |
| 510k Number | K172626 |
| Device Name: | Affinity Fusion Oxygenator With Balance Biosurface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Fusion Oxygenator With Cortiva Biosurface, Affinity Fusion Oxygenator With Cortiva BioActive Surface & Ca |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-09-01 |
| Decision Date | 2017-10-25 |
| Summary: | summary |