Polyvinyl Alcohol Embolic Microspheres
Canyon's Polyvinyl Alcohol Embolic Microspheres are nonresorbable particles used to obstruct selected vessels during embolization. Their compressible hydrogel structure is derived from…
Canyon’s Polyvinyl Alcohol Embolic Microspheres are nonresorbable particles used to obstruct selected vessels during embolization. Their compressible hydrogel structure is derived from chemically modified polyvinyl alcohol.
The hydrophilic microspheres have calibrated size ranges and are suspended in 0.9 percent saline. Blue-dyed and clear versions are supplied in sealed sterile glass vials.
Listed Item
Polyvinyl Alcohol Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials.
Particle Configurations
The family spans particle ranges from 75 to 1200 micrometers, with different volumes of microspheres per vial. Applications include arteriovenous malformations and hypervascular tumors. Uterine-fibroid use is limited to the larger specified size ranges, beginning at 500 to 700 micrometers, rather than every particle configuration.
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 | Canyon Medical Inc., China |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Manufacturer |
| 510(k) | K250209 |
| Record published | 2026-02-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB-602 | In distribution | |
| PB-601 | In distribution | |
| PW-601 | In distribution | |
| PB-801 | In distribution | |
| PB-202 | In distribution | |
| PW-203 | In distribution | |
| PB-802 | In distribution | |
| PW-101 | In distribution | |
| PW-602 | In distribution | |
| PW-403 | In distribution | |
| PW-1053 | In distribution | |
| PW-202 | In distribution | |
| PB-203 | In distribution | |
| PW-401 | In distribution | |
| PB-403 | In distribution | |
| PW-1051 | In distribution | |
| PW-1052 | In distribution | |
| PW-201 | In distribution | |
| PB-1051 | In distribution | |
| PB-803 | In distribution | |
| PB-102 | In distribution | |
| PB-1052 | In distribution | |
| PB-101 | In distribution | |
| PW-103 | In distribution | |
| PB-1053 | In distribution | |
| PW-802 | In distribution | |
| PB-201 | In distribution | |
| PW-603 | In distribution | |
| PW-402 | In distribution | |
| PB-103 | In distribution | |
| PB-603 | In distribution | |
| PW-801 | In distribution | |
| PB-402 | In distribution | |
| PW-803 | In distribution | |
| PW-102 | In distribution | |
| PB-401 | 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 |
|---|---|
| K250209 | 2025-09-23 |
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.