Optima Coil System (Optima Packing Coil System)
K-Number: K252700 · 2025-09-26
ApplicantBalt USA, LLC
Decision Date2025-09-26
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optima Coil System (Optima Packing Coil System) is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2025-09-26 under approval number K252700. 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 Packing Coil System)?
Optima Coil System (Optima Packing Coil System) is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Balt USA, LLC. The 510(k) number is K252700.
When was Optima Coil System (Optima Packing Coil System) approved by the FDA?
Optima Coil System (Optima Packing Coil System) received FDA 510(k) clearance on 2025-09-26, under approval number K252700.
What company makes Optima Coil System (Optima Packing Coil System)?
Optima Coil System (Optima Packing Coil System) is manufactured by Balt USA, LLC.
What is the FDA product code for Optima Coil System (Optima Packing Coil System)?
The FDA product code for Optima Coil System (Optima Packing Coil System) is HCG.
Other Devices by Balt USA, LLC
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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.