Target
Helical Ultra Detachable Coil
5manufacturers in China registered for this device type
73catalogue numbers in this listing
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-21 |
| Record revised | 2026-06-18 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in cool, dry, dark place. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0035452040 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035434060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035474060 | Coil Length: 6.0 Centimeter | In distribution |
| M0036181850 | Coil Length: 50.0 Centimeter | In distribution |
| M0035467200 | Secondary Coil Diameter: 7.0 Millimeter | In distribution |
| M0035443560 | Secondary Coil Diameter: 3.5 Millimeter | In distribution |
| M0036153060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035432040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035473080 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035432030 | Coil Length: 3.0 Centimeter | In distribution |
| M0035469300 | Coil Length: 30.0 Centimeter | In distribution |
| M0035477300 | Coil Length: 30.0 Centimeter | In distribution |
| M0035469200 | Secondary Coil Diameter: 9.0 Millimeter | In distribution |
| M0035467300 | Coil Length: 30.0 Centimeter | In distribution |
| M0035479300 | Coil Length: 30.0 Centimeter | In distribution |
| M0035425100 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M0035471130 | Coil Length: 30.0 Centimeter | In distribution |
| M0036157150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035433060 | Coil Length: 6.0 Centimeter | In distribution |
| M0036182450 | Coil Length: 50.0 Centimeter | In distribution |
| M0035477200 | Secondary Coil Diameter: 7.0 Millimeter | In distribution |
| M0036180820 | Secondary Coil Diameter: 8.0 Millimeter | In distribution |
| M0035453060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035421530 | Secondary Coil Diameter: 1.5 Millimeter | In distribution |
| M0035478200 | Coil Length: 20.0 Centimeter | In distribution |
| M0035474510 | Secondary Coil Diameter: 4.5 Millimeter | In distribution |
| M0035452530 | Coil Length: 3.0 Centimeter | In distribution |
| M0036182250 | Secondary Coil Diameter: 22.0 Millimeter | In distribution |
| M0035474080 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0035442540 | Coil Length: 4.0 Centimeter | In distribution |
| M0036181040 | Secondary Coil Diameter: 10.0 Millimeter | In distribution |
| M0035423580 | Secondary Coil Diameter: 3.5 Millimeter | In distribution |
| M0035465150 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M0035433080 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035452030 | Coil Length: 3.0 Centimeter | In distribution |
| M0036181650 | Secondary Coil Diameter: 16.0 Millimeter | In distribution |
| M0035474100 | Coil Length: 10.0 Centimeter | In distribution |
| M0036151030 | Coil Length: 30.0 Centimeter | In distribution |
| M0035471230 | Secondary Coil Diameter: 12.0 Millimeter | In distribution |
| M0035422040 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035467150 | Secondary Coil Diameter: 7.0 Millimeter | In distribution |
| M0035473510 | Secondary Coil Diameter: 3.5 Millimeter | In distribution |
| M0035478300 | Coil Length: 30.0 Centimeter | In distribution |
| M0036154080 | Coil Length: 8.0 Centimeter | In distribution |
| M0035424150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035452020 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035463060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035434580 | Coil Length: 8.0 Centimeter | In distribution |
| M0035466150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035442040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035477150 | Secondary Coil Diameter: 7.0 Millimeter | In distribution |
| M0035431530 | Secondary Coil Diameter: 1.5 Millimeter | In distribution |
| M0036180840 | Secondary Coil Diameter: 8.0 Millimeter | In distribution |
| M0035431020 | Secondary Coil Diameter: 1.0 Millimeter | In distribution |
| M0035463080 | Coil Length: 8.0 Centimeter | In distribution |
| M0035424100 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0035432080 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035461330 | Coil Length: 30.0 Centimeter | In distribution |
| M0036155100 | Coil Length: 10.0 Centimeter | In distribution |
| M0035468300 | Secondary Coil Diameter: 8.0 Millimeter | In distribution |
| M0035424510 | Secondary Coil Diameter: 4.5 Millimeter | In distribution |
| M0035422060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035443040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035464150 | Coil Length: 15.0 Centimeter | In distribution |
| M0036156150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035432560 | Secondary Coil Diameter: 2.5 Millimeter | In distribution |
| M0035422030 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0036180620 | Coil Length: 20.0 Centimeter | In distribution |
| M0035476150 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M0035431010 | Coil Length: 1.0 Centimeter | In distribution |
| M0035464100 | Coil Length: 10.0 Centimeter | In distribution |
| M0035421520 | Secondary Coil Diameter: 1.5 Millimeter | In distribution |
| M0035423080 | Secondary Coil Diameter: 3.0 Millimeter | 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
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.