The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nt Oxygenator With Cortiva Bioactive Surface.
| Device ID | K162016 |
| 510k Number | K162016 |
| Device Name: | Affinity NT Oxygenator With Cortiva BioActive Surface |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) Mounds View, MN 55112 |
| Contact | Renee Cveykus |
| Correspondent | Renee Cveykus MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) 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 | 2016-07-21 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169767843 | K162016 | 000 |