The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Ascent Occlusion Balloon Catheter 4x7mm,6x9mm, Micrus Summit Occlusion Balloon Catheter 4x10mm,4x15, Model Brs 00.
| Device ID | K091504 |
| 510k Number | K091504 |
| Device Name: | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Ted Ruppel |
| Correspondent | Ted Ruppel MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-06-19 |
| Summary: | summary |