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 |