The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Select Cap Arterial Cannula With Pressure Monitoring Line, Model 78818,78820,78822,78824,78918,78920,78922,78924.
| Device ID | K010737 |
| 510k Number | K010737 |
| Device Name: | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC CARDIAC SURGICAL PRODUCTS 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Marie Holm |
| Correspondent | Marie Holm MEDTRONIC CARDIAC SURGICAL PRODUCTS 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-04-04 |