The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Pixie Arterial Filter With Balance Biosurface.
| Device ID | K100646 |
| 510k Number | K100646 |
| Device Name: | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Jeffrey L Koll |
| Correspondent | Jeffrey L Koll MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994617327 | K100646 | 000 |
| 20643169878123 | K100646 | 000 |