The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Export Catheter.
| Device ID | K040869 |
| 510k Number | K040869 |
| Device Name: | EXPORT CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Fred L Boucher |
| Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994416155 | K040869 | 000 |