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 Or Balance Biosurface.
| Device ID | K100645 |
| 510k Number | K100645 |
| Device Name: | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE |
| Classification | Oxygenator, 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 | DTZ |
| Subsequent Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | DTR |
| Subsequent Product Code | FLL |
| Subsequent Product Code | JOD |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2012-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994803177 | K100645 | 000 |
| 20613994617310 | K100645 | 000 |
| 20613994617303 | K100645 | 000 |
| 20613994617273 | K100645 | 000 |
| 20613994617259 | K100645 | 000 |
| 20643169785803 | K100645 | 000 |