Galaxy G3
GALAXY G3 XSFT Microcoil Helical 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 XSFT Helical 12 Stretch Resistant Coil 2mm…
GALAXY G3 XSFT Microcoil Helical 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 XSFT Helical 12 Stretch Resistant Coil 2mm (coil diameter) x 6cm (coil length) 190cm (working length)
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 | Cerenovus, Inc., United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K171862 |
| Record published | 2016-11-16 |
| Record revised | 2026-08-03 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLX122535 | In distribution | |
| GLX120206 | In distribution | |
| GLY121230 | In distribution | |
| GLM910040 | In distribution | |
| GLY120925 | In distribution | |
| GLM920060 | In distribution | |
| GLM930060 | In distribution | |
| GLM925045 | In distribution | |
| GLY120306 | In distribution | |
| GLX120202 | In distribution | |
| GLM910010 | In distribution | |
| GLY122505 | In distribution | |
| GLY120308 | In distribution | |
| GLX120410 | In distribution | |
| GLY120407 | In distribution | |
| GLM915030 | In distribution | |
| GLM925055 | In distribution | |
| GLM910025 | In distribution | |
| GLY121030 | In distribution | |
| GLM910030 | In distribution | |
| GLY120620 | In distribution | |
| GLX120304 | In distribution | |
| GLM930080 | In distribution | |
| GLY120824 | In distribution | |
| GLX123575 | In distribution | |
| GLX120408 | In distribution | |
| GLX123505 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Codman & Shurtleff, Inc. | 510(k) number | 2019-05-16 | Class II | Error in labeling | Incorrect coil length on the label | 28 units | 2020-06-04 |
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.