The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Modification To: Export Catheter.
| Device ID | K050139 |
| 510k Number | K050139 |
| Device Name: | MODIFICATION TO: 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994416148 | K050139 | 000 |