HYDROCOIL(R) EMBOLIC SYSTEM (HES)

Device, Neurovascular Embolization

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil(r) Embolic System (hes).

Pre-market Notification Details

Device IDK112181
510k NumberK112181
Device Name:HYDROCOIL(R) EMBOLIC SYSTEM (HES)
ClassificationDevice, Neurovascular Embolization
Applicant MICROVENTION, INC. 1311 VALENCIA AVE Tustin,  CA  92780
ContactVin Cutarelli
CorrespondentVin Cutarelli
MICROVENTION, INC. 1311 VALENCIA AVE Tustin,  CA  92780
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-28
Decision Date2011-12-01
Summary:summary

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