The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Pixie Oxygenation System With; Carmeda Bioactive Surface, Balance Biosuface.
| Device ID | K141233 |
| 510k Number | K141233 |
| Device Name: | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | JOD |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-13 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169785827 | K141233 | 000 |