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.
Device ID | K162896 |
510k Number | K162896 |
Device Name: | Affinity NT Oxygenator, Affinity NT Oxygenator With Trillium Biosurface |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) Mounds View, MN 55112 |
Contact | Renee Cveykus |
Correspondent | Renee Cveykus MEDTRONIC, INC. 8200 CORAL SEA STREET NE (MVS83) Mounds View, MN 55112 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2016-10-17 |
Decision Date | 2016-12-06 |
Summary: | summary |