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 |