Impede-FX Embolization Plug
Impede-FX is a pushable embolization plug used with the Impede Embolization Plug System to reduce or obstruct blood flow in peripheral vessels. It consists of porous polyurethane foam with…
Impede-FX is a pushable embolization plug used with the Impede Embolization Plug System to reduce or obstruct blood flow in peripheral vessels. It consists of porous polyurethane foam with a platinum-iridium marker band.
The foam is compressed for catheter delivery. After deployment, body temperature and contact with fluid cause it to expand toward its original shape, filling the selected vessel region.
Listed Item
IMPEDE-FX Embolization Plug, 12mm
Delivery and Implant
The device is preloaded in an introducer with a PEEK tube and polycarbonate luer hub for transfer into a compatible catheter. The foam gradually degrades, while the device is classified as a permanent implant. It is supplied electron-beam sterilized for single use and is used only in conjunction with the Impede system.
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 | Shape Memory Medical Inc, United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182390 |
| Record published | 2019-10-31 |
| Record revised | 2025-10-31 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-03-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IMP-FX-12 | In distribution | |
| IMP-FX-08 | In distribution | |
| IMP-FX-06 | In distribution | |
| IMP-FX-12 | Withdrawn | |
| IMP-FX-08 | Withdrawn | |
| IMP-FX-06 | Withdrawn |
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 |
|---|---|
| K182390 | 2019-05-23 |
| K181051 | 2018-06-22 |
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.