The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Fusion Oxygenator With Integrated Arterial Filter And Carmeda Bioactive Surface.
Device ID | K123314 |
510k Number | K123314 |
Device Name: | AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Mary E Donlin |
Correspondent | Mary E Donlin MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-25 |
Decision Date | 2013-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169178090 | K123314 | 000 |