The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Export Xt Catheter.
| Device ID | K061958 |
| 510k Number | K061958 |
| Device Name: | MEDTRONIC EXPORT XT CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Karen A Brozowski |
| Correspondent | Karen A Brozowski MEDTRONIC VASCULAR 37A CHERRY HILL DR. 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 | 2006-07-11 |
| Decision Date | 2006-09-05 |
| Summary: | summary |