Optima Coil System

Primary DI
00810068568967
Brand
Optima Coil System
Company
BALT USA LLC
Model
OPTI3520BLK
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

Contact Domains

Product Codes

CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications

CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions

SubmissionSupplement
K223386000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810068568967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068568967008100685689678100685689670810068568967

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
00763000936594Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936600Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936617Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936624Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936648Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936655Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936679Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936716Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936730Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936747Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936754Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936761Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936778Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936785Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936792Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936808Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936815Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936822Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936839Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936846Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936853Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936860Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936877Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936884Concerto Versa™MEDTRONIC, INC.KRD2026-02-27