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 |