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 |