Cleared Traditional

i-ED COIL

K192068 · Kaneka Pharma America, LLC · Neurology
Apr 2020
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K192068 is an FDA 510(k) clearance for the i-ED COIL, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on April 25, 2020, 268 days after receiving the submission on August 1, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K192068 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2019
Decision Date April 25, 2020
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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