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 |