The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Ascent Occlusion Balloon Catheter.
| Device ID | K080861 |
| 510k Number | K080861 |
| Device Name: | MICRUS ASCENT OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-27 |
| Decision Date | 2008-08-27 |
| Summary: | summary |