I-ED COIL System

Device, Neurovascular Embolization

Kaneka Medical America LLC

The following data is part of a premarket notification filed by Kaneka Medical America Llc with the FDA for I-ed Coil System.

Pre-market Notification Details

Device IDK210638
510k NumberK210638
Device Name:I-ED COIL System
ClassificationDevice, Neurovascular Embolization
Applicant Kaneka Medical America LLC 623 Fifth Avenue New York,  NY  10022
ContactAudra Bogucki
CorrespondentTakeaki Miyata
Kaneka Corporation 1-12-32, Akasaka Minato-ku,  JP 107-6028
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-03
Decision Date2021-03-26

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