Medtronic, Inc. · Class II · Cleared Mar 25, 2015
| K-number | K143073 |
| Device name | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface |
| Applicant | Medtronic, Inc. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Mar 25, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov