The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity 38 Micon Arterial Filter With Trillium Biopassive Surface, Model 351t.
| Device ID | K013084 |
| 510k Number | K013084 |
| Device Name: | AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Marie Holm |
| Correspondent | Marie Holm 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 | No |
| Date Received | 2001-09-14 |
| Decision Date | 2001-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20721902363591 | K013084 | 000 |