The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Ultraflex Venous Cannula, Model 970xx And Cb970xx.
| Device ID | K031827 |
| 510k Number | K031827 |
| Device Name: | ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain 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 | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-07-02 |
| Summary: | summary |