EKOS+ Endovascular Device

Mechanical Thrombolysis Catheter

Boston Scientific

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

Pre-market Notification Details

Device IDK220866
510k NumberK220866
Device Name:EKOS+ Endovascular Device
ClassificationMechanical Thrombolysis Catheter
Applicant Boston Scientific Two Scimed Place Maple Grove,  MN  55311
ContactDaniel Root
CorrespondentDaniel Root
Boston Scientific Two Scimed Place Maple Grove,  MN  55311
Product CodeQEY  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-04-20

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.