The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Eopa Cap Elongated One-piece Arterial Cannula With Pressure Monitoring Line, Models 774xx, 775xx, 776xx, 777xx, 788xx,.
| Device ID | K031518 |
| 510k Number | K031518 |
| Device Name: | EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Dawn Stenstrom |
| Correspondent | Dawn Stenstrom MEDTRONIC VASCULAR 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 | 2003-05-15 |
| Decision Date | 2003-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169111424 | K031518 | 000 |
| 00643169111417 | K031518 | 000 |
| 20643169486236 | K031518 | 000 |
| 20643169486229 | K031518 | 000 |
| 20643169486212 | K031518 | 000 |
| 20613994888642 | K031518 | 000 |
| 20613994888635 | K031518 | 000 |
| 20613994888628 | K031518 | 000 |