Optima Coil System
K-Number: K200030 · 2020-02-01
ApplicantBalt USA, LLC
Decision Date2020-02-01
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optima Coil System is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2020-02-01 under approval number K200030. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optima Coil System?
Optima Coil System is a medical device that received FDA 510(k) clearance on 2020-02-01. It is manufactured by Balt USA, LLC. The 510(k) number is K200030.
When was Optima Coil System approved by the FDA?
Optima Coil System received FDA 510(k) clearance on 2020-02-01, under approval number K200030.
What company makes Optima Coil System?
Optima Coil System is manufactured by Balt USA, LLC.
What is the FDA product code for Optima Coil System?
The FDA product code for Optima Coil System is HCG.
Other Devices by Balt USA, LLC
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K161429Target Detachable CoilsStryker Neurovascular
K153658Target Detachable CoilsStryker Neurovascular
K160832Penumbra Smart CoilPenumbra, Inc.
K160096InZone Detachment SystemStryker Neurovascular
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.