Azur
The AZUR HydroPack 18 Peripheral Coil System is an implantable coil system intended to reduce or block blood flow in peripheral vessels. The filing describes use in interventional…
The AZUR HydroPack 18 Peripheral Coil System is an implantable coil system intended to reduce or block blood flow in peripheral vessels. The filing describes use in interventional radiologic management of arteriovenous malformations, fistulae, aneurysms and other peripheral vascular lesions.
Its delivery system includes an implantable coil, pusher and separately sold detachment controller. The coil has a platinum-alloy body with a hydrogel core and is delivered through a compatible microcatheter. Electrical current heats a connecting filament to detach the placed coil.
Listed Item
AZUR 18 Detachable Helical HydroCoil
Delivery and Detachment
The coil is connected to the pusher by a polyolefin elastomer filament. The AZUR Detachment Controller is packaged separately and heats the filament to release the implant.
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 |
| 510(k) | K223050 |
| Record published | 2025-04-01 |
| Record revised | 2026-04-28 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry. Keep away from sunlight. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-480810-02 | 8 mm x 10 cm | In distribution |
| 45-780308-L | 3 mm x 8 cm | In distribution |
| 45-780202-02 | 2 mm x 2 cm | In distribution |
| 45-480302-02 | 3 mm x 2 cm | In distribution |
| 45-781032-02 | 10 mm x 32 cm | In distribution |
| 45-780516-02 | 5 mm x 16 cm | In distribution |
| 45-480515-02 | 5 mm x 15 cm | In distribution |
| 45-781836-02 | 18 mm x 36 cm | In distribution |
| 45-480520-02 | 5 mm x 20 cm | In distribution |
| 45-480410-02 | 4 mm x 10 cm | In distribution |
| 45-780828-02 | 8 mm x 28 cm | In distribution |
| 45-880010 | 10 cm | In distribution |
| 45-780204-02 | 2 mm x 4 cm | In distribution |
| 45-481520-02 | 15 mm x 20 cm | In distribution |
| 45-780620-02 | 6 mm x 20 cm | In distribution |
| 45-681026-02 | 10 mm x 26 cm | In distribution |
| 45-480202-02 | 2 mm x 2 cm | In distribution |
| 45-880050 | 50 cm | In distribution |
| 45-481220-02 | 12 mm x 20 cm | In distribution |
| 45-780304-02 | 3 mm x 4 cm | In distribution |
| 45-781434-02 | 14 mm x 34 cm | In distribution |
| 45-481015-02 | 10 mm x 15 cm | In distribution |
| 45-682050-02 | 20 mm x 50 cm | In distribution |
| 45-480815-02 | 8 mm x 15 cm | In distribution |
| 45-480505-02 | 5 mm x 5 cm | In distribution |
| 45-780928-02 | 9 mm x 28 cm | In distribution |
| 45-780202-L | 2 mm x 2 cm | In distribution |
| 45-480820-02 | 8 mm x 20 cm | In distribution |
| 45-780413-02 | 4 mm x 13 cm | In distribution |
| 45-480510-02 | 5 mm x 10 cm | In distribution |
| 45-480415-02 | 4 mm x 15 cm | In distribution |
| 45-482030-02 | 20 mm x 30 cm | In distribution |
| 45-481215-02 | 12 mm x 15 cm | In distribution |
| 45-480620-02 | 6 mm x 20 cm | In distribution |
| 45-480615-02 | 6 mm x 15 cm | In distribution |
| 45-880020 | 20 cm | In distribution |
| 45-781639-02 | 16 mm x 39 cm | In distribution |
| 45-480310-02 | 3 mm x 10 cm | In distribution |
| 45-480305-02 | 3 mm x 5 cm | In distribution |
| 45-680820-02 | 8 mm x 20 cm | In distribution |
| 45-480610-02 | 6 mm x 10 cm | In distribution |
| 45-481010-02 | 10 mm x 10 cm | In distribution |
| 45-681434-02 | 14 mm x 34 cm | In distribution |
| 45-480420-02 | 4 mm x 20 cm | In distribution |
| 45-880035 | 35 cm | In distribution |
| 45-780304-L | 3 mm x 4 cm | In distribution |
| 45-782040-02 | 20 mm x 40 cm | In distribution |
| 45-481020-02 | 10 mm x 20 cm | In distribution |
| 45-480405-02 | 4 mm x 5 cm | In distribution |
| 45-781238-02 | 12 mm x 38 cm | In distribution |
| 45-880060 | 60 cm | In distribution |
| 45-780204-L | 2 mm x 4 cm | In distribution |
| 45-880005 | 5 cm | In distribution |
| 45-780308-02 | 3 mm x 8 cm | In distribution |
| 45-780724-02 | 7 mm x 24 cm | In distribution |
| 45-481515-02 | 15 mm x 15 cm | In distribution |
| 45-482020-02 | 20 mm x 20 cm | In distribution |
| 45-480204-02 | 2 mm x 4 cm | In distribution |
| 45-481530-02 | 15 mm x 30 cm | 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.