Device, Neurovascular Embolization

Kaneka Pharma America LLC

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

Pre-market Notification Details

Device IDK192068
510k NumberK192068
Device Name:I-ED COIL
ClassificationDevice, Neurovascular Embolization
Applicant Kaneka Pharma America LLC 546 Fifth Avenue 21st Floor New York,  NY  10036
ContactKazuhiko Inoue
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 Received2019-08-01
Decision Date2020-04-25

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