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 |