The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Pixie Oxygenator With Balance Biosurface, Affinity Pixie Oxygenator With Cardiotomy/venous Reservoir And Balance Biosurface, Affinity Pixie Oxygenator With Cortiva Bioactive Surface, Affinity Fusion Oxygenator With Cardiotomy/venous Reservoi.
Device ID | K172984 |
510k Number | K172984 |
Device Name: | Affinity Pixie Oxygenator With Balance Biosurface, Affinity Pixie Oxygenator With Cardiotomy/Venous Reservoir And Balance Biosurface, Affinity Pixie Oxygenator With Cortiva BioActive Surface, Affinity Fusion Oxygenator With Cardiotomy/Venous Reservoi |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Contact | Lisa Stone |
Correspondent | Lisa Stone Medtronic, Inc. 8200 Coral Sea Street NE 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 | 2017-09-27 |
Decision Date | 2017-11-20 |
Summary: | summary |