HYDROCOIL 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 Embolic System (hes).

Pre-market Notification Details

Device IDK033836
510k NumberK033836
Device Name:HYDROCOIL EMBOLIC SYSTEM (HES)
ClassificationDevice, Neurovascular Embolization
Applicant MICROVENTION, INC. 75 COLUMBIA Aliso Viejo,  CA  92656 -1408
ContactVincent Cutarelli
CorrespondentVincent Cutarelli
MICROVENTION, INC. 75 COLUMBIA Aliso Viejo,  CA  92656 -1408
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-10
Decision Date2003-12-30
Summary:summary

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