FDA.reportPublic FDA data

Optima Coil System (OptiOne Coil System)

Primary DI
00840303714545
Brand
Optima Coil System (OptiOne Coil System)
Company
BALT USA LLC
Model
OPTIONE4L
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
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K254221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254221000Optima Coil System (OptiOne Coil System)Balt USA, LLC2026-01-27HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303714545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303714545008403037145458403037145450840303714545

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.

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840303713128Carrier XL Delivery CatheterCR8088142N/A2025-10-24
00840303713135Carrier XL Delivery CatheterCR8088162N/A2025-10-24
00840303713470Carrier XL Delivery CatheterCR8088152N/A2025-10-24
00840303713593Stellar Guide CatheterSTLR071125N/A2025-08-19
00840303713609Stellar Guide CatheterSTLR081105N/A2025-08-19
00840303713616Stellar Guide CatheterSTLR081115N/A2025-08-19
00840303713531Stellar Guide CatheterSTLR071105N/A2025-06-09
00840303713548Stellar Guide CatheterSTLR071110N/A2025-06-09
00840303713555Stellar Guide CatheterSTLR071115N/A2025-06-09
00840303713562Stellar Guide CatheterSTLR074105N/A2025-06-09
00840303713579Stellar Guide CatheterSTLR074110N/A2025-06-09
00840303713586Stellar Guide CatheterSTLR074115N/A2025-06-09
00840303713487Carrier™ Delivery CatheterCR7071162N/A2025-04-02
00840303713494Carrier™ Delivery CatheterCR7074162N/A2025-04-02
00840303713500Carrier™ Delivery CatheterCR8081162N/A2025-04-02
00840303711780MEGA Ballast Distal Access PlatformMEGABT09180N/A2025-02-19
00840303711797MEGA Ballast Distal Access PlatformMEGABT09190N/A2025-02-19
00840303711803MEGA Ballast Distal Access PlatformMEGABT091100N/A2025-02-19
00840303711810MEGA Ballast Distal Access PlatformMEGABT091110N/A2025-02-19
00840303711827MEGA Ballast Distal Access PlatformMEGABT09980N/A2025-02-19

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