Cleared Special

Optima Coil System (OptiBlock Line Extension)

K242582 · Balt USA, LLC · Neurology
Sep 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K242582 is an FDA 510(k) clearance for the Optima Coil System (OptiBlock Line Extension), 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 September 27, 2024, 28 days after receiving the submission on August 30, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K242582 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2024
Decision Date September 27, 2024
Days to Decision 28 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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