Easi-Vue Embolic Microspheres System

Device, Vascular, For Promoting Embolization

ABK Biomedical Inc

The following data is part of a premarket notification filed by Abk Biomedical Inc with the FDA for Easi-vue Embolic Microspheres System.

Pre-market Notification Details

Device IDK220567
510k NumberK220567
Device Name:Easi-Vue Embolic Microspheres System
ClassificationDevice, Vascular, For Promoting Embolization
Applicant ABK Biomedical Inc 155 Chain Lake Drive Unit 32 Halifax,  CA B3S 1B3
ContactBrandi Woods
CorrespondentBrandi Woods
ABK Biomedical Inc 155 Chain Lake Drive Unit 32 Halifax,  CA B3S 1B3
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-09-07

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