The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface, Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda Bioactive Surface.
| Device ID | K142784 |
| 510k Number | K142784 |
| Device Name: | Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface, Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda BioActive Surface |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169785762 | K142784 | 000 |
| 00643169785731 | K142784 | 000 |