The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Select 3d Arterial Cannula With Carmeda Bioactive Surface And Select Cap Arterial Cannula With Carmeda Bioactive Surface.
Device ID | K033416 |
510k Number | K033416 |
Device Name: | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Brooklyn Park, MN 55428 |
Contact | Ronald W Bennett |
Correspondent | Ronald W Bennett MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Brooklyn Park, MN 55428 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-27 |
Decision Date | 2003-11-05 |
Summary: | summary |