The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nt Oxygenator With Balance Biosurface, Affinity Nt Oxygenator With Balance Biosurface And Uncoated Cardiotomy/venous Reservoir.
Device ID | K191444 |
510k Number | K191444 |
Device Name: | Affinity NT Oxygenator With Balance Biosurface, Affinity NT Oxygenator With Balance Biosurface And Uncoated Cardiotomy/Venous Reservoir |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
Contact | Harsh Dharamshi |
Correspondent | Harsh Dharamshi 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 | 2019-05-31 |
Decision Date | 2019-09-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20763000187846 | K191444 | 000 |