The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Eopa Elongated One-piece Arterial Cannula And Guidewire.
Device ID | K031037 |
510k Number | K031037 |
Device Name: | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55428 -1088 |
Contact | Ronald W Bennett |
Correspondent | Ronald W Bennett MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55428 -1088 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-01 |
Decision Date | 2003-05-13 |
Summary: | summary |