Barricade Coil System
Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and…
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.
5manufacturers in China registered for this device type
137catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Balt USA, LLC, United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2017-08-29 |
| Record revised | 2021-02-05 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at a controlled room temperature in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900131 | Complex Finish 1mm x 3cm | In distribution |
| 900119 | Complex Finish 4mm x 8cm | In distribution |
| 900124 | Complex Finish 5mm x 10cm | In distribution |
| 900117 | Complex Finish 4mm x 4cm | In distribution |
| 900030 | Helical Fill 3mm x 10cm | In distribution |
| 900086 | Fill 10-System 4mm x 20cm | In distribution |
| 900095 | Finish 10-System 2mm x 6cm | In distribution |
| 900052 | Helical Finish 2mm x 4cm | In distribution |
| 900130 | Complex Finish 1mm x 1cm | In distribution |
| 900050 | Helical Finish 2mm x 2cm | In distribution |
| 900028 | Helical Fill 3mm x 6cm | In distribution |
| 900006 | Complex Frame 5mm x 13cm | In distribution |
| 900057 | Helical Finish 3mm x 6cm | In distribution |
| 900073 | Complex Frame 10-System 9mm x 30cm | In distribution |
| 900116 | Complex Finish 3mm x 10cm | In distribution |
| 900055 | Helical Finish 2.5mm x 6cm | In distribution |
| 900089 | Fill 10-System 6mm x 25cm | In distribution |
| 900008 | Complex Frame 6mm x 16cm | In distribution |
| 900022 | Complex Frame 18-System 11mm x 29cm | In distribution |
| 900021 | Complex Frame 18-System 10mm x 27cm | In distribution |
| 900014 | Complex Frame 9mm x 23cm | In distribution |
| 900001 | Complex Frame 2.5mm x 5cm | In distribution |
| 900013 | Complex Frame 9mm x 17cm | In distribution |
| 900113 | Complex Finish 3mm x 4cm | In distribution |
| 900061 | Helical Finish 5mm x 8cm | In distribution |
| 900098 | Finish 10-System 3mm x 8cm | In distribution |
| 900034 | Helical Fill 4mm x 10cm | In distribution |
| 900072 | Complex Frame 10-System 8mm x 27cm | In distribution |
| 900035 | Helical Fill 5mm x 10cm | In distribution |
| 900025 | Complex Frame 18-System 14mm x 37cm | In distribution |
| 900092 | Fill 10-System 10mm x 40cm | In distribution |
| 900010 | Complex Frame 7mm x 19cm | In distribution |
| 900101 | Complex Finish 1mm x 2cm | In distribution |
| 900097 | Finish 10-System 2.5mm x 8cm | In distribution |
| 900107 | Complex Finish 2mm x 4cm | In distribution |
| 900127 | Helical Finish 1mm x 2cm | In distribution |
| 900039 | Helical Fill 6mm x 20cm | In distribution |
| 900024 | Complex Frame 18-System 13mm x 34cm | In distribution |
| 900121 | Complex Finish 4mm x 13cm | In distribution |
| 900026 | Complex Frame 18-system 15mm x 40cm | In distribution |
| 900036 | Helical Fill 5mm x 15cm | In distribution |
| 900083 | Complex Frame 18-System 14mm x 47cm | In distribution |
| 900040 | Helical Fill 7mm x 15cm | In distribution |
| 900069 | Complex Frame 10-System 5mm x 17cm | In distribution |
| 900051 | Helical Finish 2mm x 3cm | In distribution |
| 900074 | Complex Frame 10-System 10mm x 34cm | In distribution |
| 900012 | Complex Frame 8mm x 21cm | In distribution |
| 900059 | Helical Finish 4mm x 8cm | In distribution |
| 900037 | Helical Fill 6mm x 10cm | In distribution |
| CBL002 | In distribution | |
| 900045 | Helical Fill 10mm x 30cm | In distribution |
| 900105 | Complex Finish 2mm x 2cm | In distribution |
| 900077 | Complex Frame 18-System 8mm x 27cm | In distribution |
| 900031 | Helical Fill 4mm x 4cm | In distribution |
| 900096 | Finish 10-System 2mm x 8cm | In distribution |
| 900056 | Helical Finish 3mm x 4cm | In distribution |
| 900018 | Complex Frame 18-System 7mm x 19cm | In distribution |
| 900099 | Finish 10-System 3mm x 10cm | In distribution |
| 900004 | Complex Frame 4mm x 11cm | In distribution |
| 900029 | Helical Fill 3mm x 8cm | In distribution |
| 900043 | Helical Fill 8mm x 30cm | In distribution |
| 900134 | Complex Finish 3.5mm x 6cm | In distribution |
| 900075 | Complex Frame 18-System 6mm x 20cm | In distribution |
| 900093 | Finish 10-System 1.5mm x 4cm | In distribution |
| 900081 | Complex Frame 18-System 12mm x 40cm | In distribution |
| 900038 | Helical Fill 6mm x 15cm | In distribution |
| 900112 | Complex Finish 3mm x 3cm | In distribution |
| 900094 | Finish 10-System 1.5mm x 6cm | In distribution |
| 900079 | Complex Frame 18-System 10mm x 34cm | In distribution |
| 900063 | Helical Finish 6mm x 6cm | In distribution |
| 900053 | Helical Finish 2.5mm x 3cm | In distribution |
| 900109 | Complex Finish 2.5mm x 2cm | In distribution |
| 900049 | Helical Finish 2mm x 1cm | In distribution |
| 900080 | Complex Frame 18-System 11mm x 37cm | In distribution |
| 900032 | Helical Fill 4mm x 6cm | In distribution |
| 900122 | Complex Finish 5mm x 6cm | In distribution |
| 900118 | Complex Finish 4mm x 6cm | In distribution |
| 900062 | Helical Finish 5mm x 10cm | In distribution |
| 900133 | Complex Finish 3.5mm x 4cm | In distribution |
| 900065 | Helical Finish 6mm x 10cm | In distribution |
| 900108 | Complex Finish 2mm x 6cm | In distribution |
| 900066 | In distribution | |
| 900111 | Complex Finish 2.5mm x 4cm | In distribution |
| 900041 | Helical Fill 7mm x 20cm | In distribution |
| 900132 | Complex Finish 3.5mm x 3cm | In distribution |
| 900027 | Helical Fill 3mm x 4cm | In distribution |
| 900005 | Complex Frame 5mm x 9cm | In distribution |
| 900064 | Helical Finish 6mm x 8cm | In distribution |
| 900085 | Fill 10-System 4mm x 15cm | In distribution |
| 900002 | Complex Frame 3mm x 6cm | In distribution |
| 900044 | Helical Fill 9mm x 30cm | In distribution |
| 900068 | Complex Frame 10-System 4mm x 13cm | In distribution |
| 900106 | Complex Finish 2mm x 3cm | In distribution |
| 900102 | Complex Finish 1.5mm x 2cm | In distribution |
| 900129 | Helical Finish 1mm x 4cm | In distribution |
| 900104 | Complex Finish 1.5mm x 4cm | In distribution |
| 900110 | Complex Finish 2.5mm x 3cm | In distribution |
| 900091 | Fill 10-System 7mm x 30cm | In distribution |
| 900042 | Helical Fill 8mm x 20cm | In distribution |
| 900078 | Complex Frame 18-System 9mm x 30cm | In distribution |
| 900000 | Complex Frame 2mm x 3cm | In distribution |
| 900033 | Helical Fill 4mm x 8cm | In distribution |
| 900090 | Fill 10-System 6mm x 30cm | In distribution |
| 900120 | Complex Finish 4mm x 10cm | In distribution |
| 900084 | Complex Frame 18-System 15mm x 50cm | In distribution |
| 900088 | Fill 10-System 5mm x 25cm | In distribution |
| 900087 | Fill 10-System 5mm x 20cm | In distribution |
| 900009 | Complex Frame 7mm x 13cm | In distribution |
| 900011 | Complex Frame 8mm x 16cm | In distribution |
| 900015 | Complex Frame 10mm x 21cm | In distribution |
| 900046 | Helical Finish 1.5mm x 1cm | In distribution |
| 900115 | Complex Finish 3mm x 8cm | In distribution |
| 900114 | Complex Finish 3mm x 6cm | In distribution |
| 900019 | Complex Frame 18-System 8mm x 21cm | In distribution |
| 900123 | Complex Finish 5mm x 8cm | In distribution |
| 900125 | Complex Finish 5mm x 13cm | In distribution |
| 900076 | Complex Frame 18-System 7mm x 24cm | In distribution |
| 900023 | Complex Frame 18-System 12mm x 31cm | In distribution |
| 900103 | Complex Finish 1.5mm x 3cm | In distribution |
| 900007 | Complex Frame 6mm x 11cm | In distribution |
| 900047 | Helical Finish 1.5mm x 2cm | In distribution |
| 900082 | Complex Frame 18-System 13mm x 43cm | In distribution |
| 900054 | Helical Finish 2.5mm x 4cm | In distribution |
| 900070 | Complex Frame 10-System 6mm x 20cm | In distribution |
| 900048 | Helical Finish 1.5mm x 3cm | In distribution |
| 900017 | Complex Frame 18-System 6mm x 16cm | In distribution |
| 900020 | Complex Frame 18-System 9mm x 23cm | In distribution |
| 900126 | Helical Finish 1mm x 1cm | In distribution |
| 900071 | Complex Frame 10-System 7mm x 24cm | In distribution |
| 900058 | Helical Finish 4mm x 6cm | In distribution |
| 900003 | Complex Frame 4mm x 7cm | In distribution |
| 900100 | Finish 10-System 4mm x 10cm | In distribution |
| 900016 | Complex Frame 10mm x 27cm | In distribution |
| 900128 | Helical Finish 1mm x 3cm | In distribution |
| 900060 | Helical Finish 5mm x 6cm | In distribution |
| 900067 | In distribution | |
| 900135 | Complex Finish 3.5mm x 8cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
| Trufill DCS Orbit | Cerenovus, Inc. | 74 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254221 | 2026-01-27 |
| K252700 | 2025-09-26 |
| K242582 | 2024-09-27 |
| K223386 | 2022-12-06 |
| K200030 | 2020-02-01 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-05-08 | Class II | Vendor change control | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. | 2889 devices |
| 2024-01-03 | Class II | Material/Component Contamination | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the d | 31785 coils |
| 2022-09-07 | Class II | Error in labeling | Product pouch label does not match up with carton label | 41 impacted devices |
| 2022-07-26 | Class II | Under Investigation by firm | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. | 4 devices |
| 2022-01-04 | Class II | Process control | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting th | 51 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.