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Optima Coil System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K200030

by Balt Usa Llc

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
OPTI0412HSFMX 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
00818053025495 FDA UDI
510(k) Number
K200030 FDA 510(k)FDA UDI
FDA Product Code
HCG FDA 510(k)FDA UDI
KRD FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.5950 FDA 510(k)
Regulation Number
882.5950 FDA 510(k)FDA UDI
870.3300 FDA UDI
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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
MRI Safety
MR Conditional FDA UDI

Optima Coil System by Balt Usa Llc — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Balt Usa Llc
FDA Applicant
Balt USA, LLC

Sources (2)

  • FDA 510(k) K200030 24 fields · synced Jun 18, 2026
  • FDA UDI 6cb0bd57-a9e7-4d62-b9b3-e7a027de1779 38 fields · synced May 27, 2026