Cleared Special

Optima Coil System

K200030 · Balt USA, LLC · Neurology
Feb 2020
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K200030 is an FDA 510(k) clearance for the Optima Coil System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on February 1, 2020, 25 days after receiving the submission on January 7, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K200030 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2020
Decision Date February 01, 2020
Days to Decision 25 days
Submission Type Special
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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