The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nt Oxygenator, Affinity Nt Oxygenator With Trillium Biosurface, Affinity Nt Oxygenator With Carmeda Biosurface.
Device ID | K143073 |
510k Number | K143073 |
Device Name: | Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface, Affinity NT Oxygenator With Carmeda 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 |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-27 |
Decision Date | 2015-03-25 |
Summary: | summary |