Optima Coil System

Primary DI
00810068568752
Brand
Optima Coil System
Company
BALT USA LLC
Model
OPTI0635BLK
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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HCGDevice, Neurovascular Embolization

Product Code Classifications

CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions

SubmissionSupplement
K223386000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223386000Optima Coil SystemBalt USA, LLC2022-12-06HCG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810068568752PrimaryGS10

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature in a dry place.

Sterilization Methods

Method

Contacts

PhoneEmail
1-949-788-1443customerservice@balt-usa.com

Regulatory Flags

DUNS number
945543689
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840303714262Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714279Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714286Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714293Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714309Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714316Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714323Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714330Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714347Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714354Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714361Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714378Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714385Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714392Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714408Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714415Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714422Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714439Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714446Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714453Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714460Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714477Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00840303714484Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-01-28
00810169722039swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722046swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722053swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722060swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722077swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722084swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26
00810169722091swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-01-26