Optima Coil System

Primary DI
00840303712466
Brand
Optima Coil System
Company
BALT USA LLC
Model
OPTI0320BLK
Catalog number
N/A
Device description
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
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242582000Optima Coil System (OptiBlock Line Extension)Balt USA, LLC2024-09-27HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303712466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303712466008403037124668403037124660840303712466

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature in a dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-949-788-1443customerservice@balt-usa.com

Regulatory Flags#

DUNS number
945543689
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840303714255Optima Coil System (OptiOne Coil System)OPTIONE3SN/A2026-01-28
00840303714262Optima Coil System (OptiOne Coil System)OPTIONE3MN/A2026-01-28
00840303714279Optima Coil System (OptiOne Coil System)OPTIONE3LN/A2026-01-28
00840303714286Optima Coil System (OptiOne Coil System)OPTIONE35SN/A2026-01-28
00840303714293Optima Coil System (OptiOne Coil System)OPTIONE35MN/A2026-01-28
00840303714309Optima Coil System (OptiOne Coil System)OPTIONE35LN/A2026-01-28
00840303714316Optima Coil System (OptiOne Coil System)OPTIONE4SN/A2026-01-28
00840303714323Optima Coil System (OptiOne Coil System)OPTIONE4MN/A2026-01-28
00840303714330Optima Coil System (OptiOne Coil System)OPTIONE4LN/A2026-01-28
00840303714347Optima Coil System (OptiOne Coil System)OPTIONE45SN/A2026-01-28
00840303714354Optima Coil System (OptiOne Coil System)OPTIONE45MN/A2026-01-28
00840303714361Optima Coil System (OptiOne Coil System)OPTIONE45LN/A2026-01-28
00840303714378Optima Coil System (OptiOne Coil System)OPTIONE5SN/A2026-01-28
00840303714385Optima Coil System (OptiOne Coil System)OPTIONE5MN/A2026-01-28
00840303714392Optima Coil System (OptiOne Coil System)OPTIONE5LN/A2026-01-28
00840303714408Optima Coil System (OptiOne Coil System)OPTIONE5XLN/A2026-01-28
00840303714415Optima Coil System (OptiOne Coil System)OPTIONE55SN/A2026-01-28
00840303714422Optima Coil System (OptiOne Coil System)OPTIONE55MN/A2026-01-28
00840303714439Optima Coil System (OptiOne Coil System)OPTIONE55LN/A2026-01-28
00840303714446Optima Coil System (OptiOne Coil System)OPTIONE55XLN/A2026-01-28

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