IDC INTERLOCKING DETACHABLE COIL

Device, Vascular, For Promoting Embolization

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Idc Interlocking Detachable Coil.

Pre-market Notification Details

Device IDK141378
510k NumberK141378
Device Name:IDC INTERLOCKING DETACHABLE COIL
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Boston Scientific Corporation ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactLiz Johnston
CorrespondentLiz Johnston
Boston Scientific Corporation ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2014-10-08
Summary:summary

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