The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Af100 Arterial Filter With Balance Biosurface.
Device ID | K122760 |
510k Number | K122760 |
Device Name: | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Julia A Nelson |
Correspondent | Julia A Nelson 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 | 2012-09-10 |
Decision Date | 2012-12-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20643169178124 | K122760 | 000 |