Optima Coil System (OptiOne Coil System) N/A

GUDID 00840303714286

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

BALT USA LLC

Neurovascular embolization coil

• Primary Device ID: 00840303714286
• NIH Device Record Key: 41ef16d3-b062-44c7-9fb7-b8c55043663a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima Coil System (OptiOne Coil System)
• Version Model Number: OPTIONE35S
• Catalog Number: N/A
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840303714286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252700

FDA Product Code

• HCG: Device, Neurovascular Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-05
• Device Publish Date: 2026-01-28

On-Brand Devices [Optima Coil System (OptiOne Coil System)]

• 00840303714484: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714477: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714460: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714453: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714446: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714439: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714422: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714415: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714408: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714392: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714385: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714378: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714361: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714354: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714347: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714330: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714323: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714316: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714309: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714293: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714286: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714279: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714262: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u
• 00840303714255: The Optima Coil System is a series of specialized coils that are inserted into the vasculature u