BARRICADE EMBOLIZATION COIL SYSTEM

Device, Neurovascular Embolization

BLOCKADE MEDICAL

The following data is part of a premarket notification filed by Blockade Medical with the FDA for Barricade Embolization Coil System.

Pre-market Notification Details

Device IDK123338
510k NumberK123338
Device Name:BARRICADE EMBOLIZATION COIL SYSTEM
ClassificationDevice, Neurovascular Embolization
Applicant BLOCKADE MEDICAL 18 Technology Dr Ste 169 Irvine,  CA  92618
ContactRebecca K Pine
CorrespondentRebecca K Pine
BLOCKADE MEDICAL 18 Technology Dr Ste 169 Irvine,  CA  92618
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2013-03-28
Summary:summary

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