i-ED Coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
5manufacturers in China registered for this device type
53catalogue 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 | Kaneka Corporation, Japan |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| 510(k) | K210638 |
| Record published | 2022-05-24 |
| Record revised | 2023-09-11 (version 4) |
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 a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 371-041015 | Helical (Infini Extra Soft) 10inch 4-10mm x 15cm | In distribution |
| 390-01H4 | Complex (Silky Soft) 10inch 1.5mm x 4cm | In distribution |
| 390-0204 | Complex (Silky Soft) 10inch 2mm x 4cm | In distribution |
| 392-0730 | Complex (Soft) 12inch 7mm x 30cm | In distribution |
| 393-020320 | Complex (Infini Silky Soft) 12inch 2-3mm x 20cm | In distribution |
| 390-02H6 | Complex (Silky Soft) 10inch 2.5mm x 6cm | In distribution |
| 390-0203 | Complex (Silky Soft) 10inch 2mm x 3cm | In distribution |
| 390-01H2 | Complex (Silky Soft) 10inch 1.5mm x 2cm | In distribution |
| 392-0620 | Complex (Soft) 12inch 6mm x 20cm | In distribution |
| 390-0102 | Complex (Silky Soft) 10inch 1mm x 2cm | In distribution |
| 390-01H3 | Complex (Silky Soft) 10inch 1.5mm x 3cm | In distribution |
| 392-0615 | Complex (Soft) 12inch 6mm x 15cm | In distribution |
| 393-020310 | Complex (Infini Silky Soft) 12inch 2-3mm x 10cm | In distribution |
| 392-1040 | Complex (Medium Soft) 14inch 10mm x 40cm | In distribution |
| 390-0304 | Complex (Silky Soft) 10inch 3mm x 4cm | In distribution |
| 393-030510 | Complex (Infini Silky Soft) 12inch 3-5mm x 10cm | In distribution |
| 393-030520 | Complex (Infini Silky Soft) 12inch 3-5mm x 20cm | In distribution |
| 392-0510 | Complex (Soft) 12inch 5mm x 10cm | In distribution |
| 390-0101 | Complex (Silky Soft) 10inch 1mm x 1cm | In distribution |
| 393-030515 | Complex (Infini Silky Soft) 12inch 3-5mm x 15cm | In distribution |
| 373-040830 | Helical (Infini Extra Soft) 14inch 4-8mm x 30cm | In distribution |
| 393-030530 | Complex (Infini Silky Soft) 12inch 3-5mm x 30cm | In distribution |
| 392-0720 | Complex (Soft) 12inch 7mm x 20cm | In distribution |
| 390-0208 | Complex (Silky Soft) 10inch 2mm x 8cm | In distribution |
| 390-0308 | Complex (Silky Soft) 10inch 3mm x 8cm | In distribution |
| 372-041030 | Helical (Infini Soft) 10inch 4-10mm x 30cm | In distribution |
| 373-040815 | Helical (Infini Extra Soft) 14inch 4-8mm x 15cm | In distribution |
| 373-122050 | Helical (Infini Standard) 14inch 12-20mm x 50cm | In distribution |
| 392-0304 | Complex (Extra Soft) 10inch 3mm x 4cm | In distribution |
| 373-051230 | Helical (Infini Soft) 14inch 5-12mm x 30cm | In distribution |
| 371-041010 | Helical (Infini Extra Soft) 10inch 4-10mm x 10cm | In distribution |
| 392-03H8 | Complex (Extra Soft) 10inch 3.5mm x 8cm | In distribution |
| 393-020306 | Complex (Infini Silky Soft) 12inch 2-3mm x 6cm | In distribution |
| 392-0408 | Complex (Soft) 10inch 4mm x 8cm | In distribution |
| 392-0306 | Complex (Extra Soft) 10inch 3mm x 6cm | In distribution |
| 390-0206 | Complex (Silky Soft) 10inch 2mm x 6cm | In distribution |
| 390-0103 | Complex (Silky Soft) 10inch 1mm x 3cm | In distribution |
| 393-020330 | Complex (Infini Silky Soft) 12inch 2-3mm x 30cm | In distribution |
| 392-0515 | Complex (Soft) 12inch 5mm x 15cm | In distribution |
| 372-041020 | Helical (Infini Soft) 10inch 4-10mm x 20cm | In distribution |
| 392-1250 | Complex (Medium Soft) 14inch 12mm x 50cm | In distribution |
| 392-1650 | Complex (Standard) 14inch 16mm x 50cm | In distribution |
| 392-0410 | Complex (Soft) 10inch 4mm x 10cm | In distribution |
| 392-0840 | Complex (Soft) 14inch 8mm x 40cm | In distribution |
| 392-1450 | Complex (Standard) 14inch 14mm x 50cm | In distribution |
| 374-142450 | Helical (Infini Standard) 17inch 14-24mm x 50cm | In distribution |
| 373-040810 | Helical (Infini Extra Soft) 14inch 4-8mm x 10cm | In distribution |
| 390-0306 | Complex (Silky Soft) 10inch 3mm x 6cm | In distribution |
| 392-0940 | Complex (Soft) 14inch 9mm x 40cm | In distribution |
| 393-020304 | Complex (Infini Silky Soft) 12inch 2-3mm x 4cm | In distribution |
| 373-051250 | Helical (Infini Soft) 14inch 5-12mm x 50cm | In distribution |
| 390-0212 | Complex (Silky Soft) 10inch 2mm x 12cm | In distribution |
| 390-02H4 | Complex (Silky Soft) 10inch 2.5mm x 4cm | 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.