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 |
| 20763000232089 | K191029 | 000 |
| 20763000232140 | K191029 | 000 |