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 |