Impede Embolization Plug
IMPEDE is an embolization plug for reducing or obstructing blood flow in peripheral vessels. It combines a self-expanding polyurethane-based foam plug with a distal helical anchor coil,…
IMPEDE is an embolization plug for reducing or obstructing blood flow in peripheral vessels. It combines a self-expanding polyurethane-based foam plug with a distal helical anchor coil, Nitinol core wire and proximal marker band.
The crimped plug is delivered through a catheter from a preloaded introducer sheath. Exposure to blood and body temperature causes the porous foam to expand and conform to the vessel, while the anchor coil helps stabilize its position.
Listed Item
IMPEDE Embolization Plug, 10mm
Implant and Introducer
The anchor coil and marker band are platinum-iridium alloy. The introducer has a PEEK tube and polycarbonate Luer hub. The assembled unit is supplied sterile for single use. The device is classed as a permanent implant even though its foam component gradually degrades.
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) | K181051 |
| Record published | 2020-04-02 |
| 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-07 | In distribution | |
| IMP-10 | In distribution | |
| IMP-05 | In distribution | |
| IMP-07 | Withdrawn | |
| IMP-05 | Withdrawn | |
| IMP-10 | 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.