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
- OPTI0206CSSMX 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
- 00818053025006 FDA UDI
- 510(k) Number
- K200030 FDA UDI
- FDA Product Code
- KRD FDA UDIHCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI882.5950 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
Similar devices
Also classified as Neurovascular embolization coil.
- HydroSoft Helical — MICROVENTION INC. · Class II
- Target — Stryker Corp. · Class II
- Axium PrimeTM — Micro Therapeutics, Inc. · Class II
- AxiumTM — Micro Therapeutics, Inc. · Class II
- WEB Aneurysm Embolization System — SEQUENT MEDICAL, INC. · Class III
- WEB Aneurysm Embolization System — MICROVENTION INC. · Class III
- HydroFill Helical — MICROVENTION INC. · Class II
- TARGET — Stryker Corp. · Class II
Cleared under the same submission
K200030 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Balt Usa Llc
Sources (1)
- FDA UDI 6e3a2eae-8a73-4852-a6d4-12a598b85c7f 38 fields · synced May 30, 2026