The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity 20u Arterial Filter With Trillium Biosurface.
| Device ID | K033468 |
| 510k Number | K033468 |
| Device Name: | AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Michele Pyfferoen |
| Correspondent | Michele Pyfferoen MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-11-03 |
| Decision Date | 2003-11-14 |
| Summary: | summary |