The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Scepter Xc Occlusion Balloon Catheter.
| Device ID | K113698 |
| 510k Number | K113698 |
| Device Name: | SCEPTER XC OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-01-13 |
| Summary: | summary |