Barricade Coil System - Barricade Coil System (BCS) is intended for the - BALT USA LLC

Duns Number:945543689

Device Description: Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial 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.

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More Product Details

Catalog Number

900000

Brand Name

Barricade Coil System

Version/Model Number

900000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HCG

Product Code Name

Device, Neurovascular Embolization

Device Record Status

Public Device Record Key

0b563f7b-cd41-448d-add5-4099c4c28a4b

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BALT USA LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 757