FDA.reportPublic FDA data

Barricade Coil System

Primary DI
00818053021046
Brand
Barricade Coil System
Company
BALT USA LLC
Model
900105
Catalog number
900105
Device description
Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS is also intended 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 embolizations in the peripheral vasculature. The BCS consists of an implantable coil attached to a delivery pusher. The delivery pusher is powered by the Blockade Detachment Controller (BDC) designed specifically for the BCS. The device comes pre-loaded with one 9-volt battery. A BlockWire Connecting Cable or Handheld Detachment Cable, comprised of a red and black cable leads are required to detach Barricade Detachable Coils and must be used in conjunction with a return electrode.
Published
2017-08-29
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818053021046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818053021046008180530210468180530210460818053021046

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA sterile, 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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
949-788-1443xxx@xx.xx

Regulatory Flags#

DUNS number
945543689
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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