The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Mc2x Multi-stage Venous Cannula.
Device ID | K031776 |
510k Number | K031776 |
Device Name: | MC2X MULTI-STAGE VENOUS CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Ronald W Bennett |
Correspondent | Ronald W Bennett MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2003-06-10 |
Decision Date | 2003-07-25 |
Summary: | summary |