The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Nttm Oxygenator (model 511), Affinity® Nt Hollow Fiber Oxygenator With Plasma Resistant Fiber (prf) With Trilliumtm Biosurface (model 511t), Affinity® Nt Integrated Cvr/membrane Oxygenator With Plasma Resistant Fiber (model 541), Affinity® N.
Device ID | K191029 |
510k Number | K191029 |
Device Name: | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator With Plasma Resistant Fiber (PRF) With TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator With Plasma Resistant Fiber (Model 541), Affinity® N |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
Contact | Sammie C Joseph-fredericks |
Correspondent | Sammie C Joseph-fredericks Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-18 |
Decision Date | 2019-05-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20763000232126 | K191029 | 000 |
20613994375630 | K191029 | 000 |
20613994375654 | K191029 | 000 |
20613994375678 | K191029 | 000 |
20681490791100 | K191029 | 000 |
20721902673331 | K191029 | 000 |
20613994375647 | K191029 | 000 |
20763000232140 | K191029 | 000 |
20763000232089 | K191029 | 000 |
20613994375623 | K191029 | 000 |