EkoSonic Endovascular Device

Mechanical Thrombolysis Catheter

Boston Scientific

The following data is part of a premarket notification filed by Boston Scientific with the FDA for Ekosonic Endovascular Device.

Pre-market Notification Details

Device IDK211080
510k NumberK211080
Device Name:EkoSonic Endovascular Device
ClassificationMechanical Thrombolysis Catheter
Applicant Boston Scientific Two Scimed Place Maple Grove,  MN  55311
ContactJoshua Kim
CorrespondentDaniel Root
Boston Scientific Two Scimed Place Maple Grove,  MN  55311
Product CodeQEY  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-11-19

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