The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Medtronic Dlp Arterial Cannulae With 3d Tip.
| Device ID | K000776 |
| 510k Number | K000776 |
| Device Name: | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-10 |
| Decision Date | 2001-02-07 |