Target
Helical Ultra Detachable Coil
6manufacturers in China registered for this device type
62catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-21 |
| Record revised | 2024-10-08 (version 5) |
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 |
|---|---|---|
| M0035476200 | Coil Length: 20.0 Centimeter | In distribution |
| M0035423060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035461030 | Secondary Coil Diameter: 10.0 Millimeter | In distribution |
| M0036180640 | Coil Length: 40.0 Centimeter | In distribution |
| M0035433100 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0036181240 | Secondary Coil Diameter: 12.0 Millimeter | In distribution |
| M0035471430 | Coil Length: 30.0 Centimeter | In distribution |
| M0035433040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035479200 | Coil Length: 20.0 Centimeter | In distribution |
| M0035434150 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0035432020 | Coil Length: 2.0 Centimeter | In distribution |
| M0035431540 | Coil Length: 4.0 Centimeter | In distribution |
| M0035452060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035468200 | Coil Length: 20.0 Centimeter | In distribution |
| M0035433560 | Secondary Coil Diameter: 3.5 Millimeter | In distribution |
| M0035475100 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M0035461130 | Secondary Coil Diameter: 11.0 Millimeter | In distribution |
| M0035421030 | Secondary Coil Diameter: 1.0 Millimeter | In distribution |
| M0036158250 | Coil Length: 25.0 Centimeter | In distribution |
| M0035424080 | Coil Length: 8.0 Centimeter | In distribution |
| M0035442030 | Coil Length: 3.0 Centimeter | In distribution |
| M0035423040 | Coil Length: 4.0 Centimeter | In distribution |
| M0036181450 | Coil Length: 50.0 Centimeter | In distribution |
| M0035453040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035475200 | Coil Length: 20.0 Centimeter | In distribution |
| M0036180520 | Coil Length: 20.0 Centimeter | In distribution |
| M0035453080 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035472040 | Coil Length: 4.0 Centimeter | In distribution |
| M0035466200 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M0035452540 | Secondary Coil Diameter: 2.5 Millimeter | In distribution |
| M0035471030 | Coil Length: 30.0 Centimeter | In distribution |
| M0036180630 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M0035461540 | Secondary Coil Diameter: 15.0 Millimeter | In distribution |
| M0035432060 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035473060 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035464080 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0035473100 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035421020 | Coil Length: 2.0 Centimeter | In distribution |
| M0036182050 | Coil Length: 50.0 Centimeter | In distribution |
| M0035425150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035423100 | Coil Length: 10.0 Centimeter | In distribution |
| M0035476100 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M0035431510 | Secondary Coil Diameter: 1.5 Millimeter | In distribution |
| M0035466300 | Coil Length: 30.0 Centimeter | In distribution |
| M0035432010 | Secondary Coil Diameter: 2.0 Millimeter | In distribution |
| M0035432540 | Coil Length: 4.0 Centimeter | In distribution |
| M0035443060 | Secondary Coil Diameter: 3.0 Millimeter | In distribution |
| M0035422540 | Secondary Coil Diameter: 2.5 Millimeter | In distribution |
| M0035475150 | Coil Length: 15.0 Centimeter | In distribution |
| M0035424060 | Coil Length: 6.0 Centimeter | In distribution |
| M0035432530 | Secondary Coil Diameter: 2.5 Millimeter | In distribution |
| M0035421540 | Coil Length: 4.0 Centimeter | In distribution |
| M0035434080 | Coil Length: 8.0 Centimeter | In distribution |
| M0035476300 | Secondary Coil Diameter: 6.0 Millimeter | In distribution |
| M0035431520 | Secondary Coil Diameter: 1.5 Millimeter | In distribution |
| M0035431030 | Secondary Coil Diameter: 1.0 Millimeter | In distribution |
| M0035471330 | Secondary Coil Diameter: 13.0 Millimeter | In distribution |
| M0035461230 | Coil Length: 30.0 Centimeter | In distribution |
| M0035465200 | Secondary Coil Diameter: 5.0 Millimeter | In distribution |
| M0035474150 | Secondary Coil Diameter: 4.0 Millimeter | In distribution |
| M0035452560 | Secondary Coil Diameter: 2.5 Millimeter | In distribution |
| M0035461430 | Secondary Coil Diameter: 14.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120816 | 2012-04-17 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
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.