Azur Detachment Controller
3 catalogue numbers from 45-4001-AL, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.
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 | MicroVention, 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, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2025-09-01 |
| Record revised | 2026-04-28 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 60 °C; Storage environment humidity up to 75 % RH |
| Packaging | Carton of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-4001-AL | In distribution | |
| 45-4001 | 0 | In distribution |
| 45-4001-02 | 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 |
|---|---|
| K223050 | 2022-12-21 |
| K191680 | 2020-03-20 |
| K162524 | 2017-03-03 |
| K150870 | 2015-12-21 |
| K151358 | 2015-09-25 |
| K150958 | 2015-09-17 |
| K133626 | 2013-12-20 |
| K132083 | 2013-10-28 |
| K130577 | 2013-06-17 |
| K122543 | 2012-11-28 |
| K123384 | 2012-11-28 |
| K122316 | 2012-08-29 |
| K120630 | 2012-03-28 |
| K111307 | 2011-06-15 |
| K102365 | 2010-11-18 |
| K093002 | 2009-10-28 |
| K091882 | 2009-07-08 |
| K071939 | 2008-01-11 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-29 | Class II | Device Design | Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, bl | 1451 | |
| 2023-08-24 | Class II | Process control | Peripheral coil system detachable has a potential of unsealed pouch packaging. | 14 | |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 392 units | 2021-04-20 |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 1,187 units | 2021-04-20 |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 107 units | 2021-04-20 |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 19 units | 2021-04-20 |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 3,881 units | 2021-04-20 |
| 2019-11-24 | Class II | Other | The devices may be missing the implant coil. | 445 units | 2021-04-20 |
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.