The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Modification To Export Aspiration Catheter.
| Device ID | K030201 |
| 510k Number | K030201 |
| Device Name: | MODIFICATION TO EXPORT ASPIRATION CATHETER |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| 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 | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-03-26 |
| Summary: | summary |