AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

Device, Vascular, For Promoting Embolization

MICRO VENTION, INC.

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.

Pre-market Notification Details

Device IDK132083
510k NumberK132083
Device Name:AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
ClassificationDevice, Vascular, For Promoting Embolization
Applicant MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
ContactLaraine Pangelina
CorrespondentLaraine Pangelina
MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin,  CA  92780
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-05
Decision Date2013-10-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.