The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Azur Pure Peripheral Coil Systems, Pushable 35.
Device ID | K132083 |
510k Number | K132083 |
Device Name: | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 |
Classification | Device, Vascular, For Promoting Embolization |
Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Contact | Laraine Pangelina |
Correspondent | Laraine Pangelina MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Product Code | KRD |
CFR Regulation Number | 870.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-05 |
Decision Date | 2013-10-28 |
Summary: | summary |