The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Medtronic Dlp Arterial Cannula With 3d Tip - 22 Fr..
| Device ID | K013013 |
| 510k Number | K013013 |
| Device Name: | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids, MI 49504 -6393 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids, MI 49504 -6393 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-07 |
| Decision Date | 2001-12-04 |
| Summary: | summary |