Hilal
Hilal Embolization Microcoil
5manufacturers in China registered for this device type
19catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G04523 | 2 | In distribution | |
| G08125 | 2 | In distribution | |
| G07155 | 2 | In distribution | |
| G07154 | 2 | In distribution | |
| G04522 | 2 | In distribution | |
| G04621 | 2 | In distribution | |
| G05017 | 2 | In distribution | |
| G07158 | 2 | In distribution | |
| G04524 | 2 | In distribution | |
| G07157 | 2 | In distribution | |
| G04525 | 2 | In distribution | |
| G07160 | 2 | In distribution | |
| G07156 | 2 | In distribution | |
| G07159 | 2 | In distribution | |
| G07161 | 2 | In distribution | |
| G04619 | 2 | In distribution | |
| G04622 | 2 | In distribution | |
| G07153 | 2 | In distribution | |
| G04620 | 2 | 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 |
| Barricade Coil System | Balt USA, LLC | 137 |
| 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 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000651 | 2000-11-24 |
| K901337 | 1990-11-13 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-05-08 | Not classified | Labeling Change Control | The product length is declared incorrectly in mm when the unit of measurement should be cm. | 180 | 2008-10-21 |
| 2008-05-08 | Not classified | Labeling Change Control | The product length is declared incorrectly in mm when the unit of measurement should be cm. | 1183 | 2008-10-21 |
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.