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 IDK151760
510k NumberK151760
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-29
Decision Date2015-07-27
Summary:summary

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