Identity
- Trade Name
- Optima Coil System FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller. FDA UDI
- Model / Reference
- OPTI0103HSS10 FDA UDI
- Description
- The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00818053026591 FDA UDI
- 510(k) Number
- K172390 FDA UDI
- FDA Product Code
- HCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Neurovascular embolization coil
Optima Coil System by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Neurovascular embolization coil.
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- HydroFill Helical — MICROVENTION INC. · Class II
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Cleared under the same submission
K172390 also covers:
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
- Optima Coil System — BALT USA LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Balt Usa Llc
Sources (1)
- FDA UDI 22ceafb9-6b74-443d-a9df-cf2963abcf53 38 fields · synced May 30, 2026