The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Export Ap Catheter.
| Device ID | K081573 |
| 510k Number | K081573 |
| Device Name: | MEDTRONIC EXPORT AP CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Tara N Turney |
| Correspondent | Tara N Turney MEDTRONIC VASCULAR 37A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-05 |
| Decision Date | 2008-06-27 |
| Summary: | summary |