The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Eopa Elongated One-piece Arterial Cannula With Guidewire.
| Device ID | K000274 |
| 510k Number | K000274 |
| Device Name: | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON S.W. Grand Rapids, MI 49504 |
| Contact | James Balun |
| Correspondent | James Balun MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON S.W. Grand Rapids, MI 49504 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-02-10 |