Azur Detachable Helical HydroCoil
61 catalogue numbers from 45-481215, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
61catalogue numbers in this listing
18510(k) clearances naming this product code
8recalls on this 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 | 2015-12-29 |
| Record revised | 2026-04-28 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-481215 | 12 mm x 15 cm | In distribution |
| 45-450510 | 5 mm x 10 cm | In distribution |
| 45-481020 | 10 mm x 20 cm | In distribution |
| 45-450505 | 5 mm x 5 cm | In distribution |
| 45-480620 | 6 mm x 20 cm | In distribution |
| 45-451220 | 12 mm x 20 cm | In distribution |
| 45-480810 | 8 mm x 10 cm | In distribution |
| 45-481520 | 15 mm x 20 cm | In distribution |
| 45-452020 | 20 mm x 20 cm | In distribution |
| 45-450305 | 3 mm x 5 cm | In distribution |
| 45-481515 | 15 mm x 15 cm | In distribution |
| 45-450415 | 4 mm x 15 cm | In distribution |
| 45-480610 | 6 mm x 10 cm | In distribution |
| 45-452030 | 20 mm x 30 cm | In distribution |
| 45-480305 | 3 mm x 5 cm | In distribution |
| 45-480615 | 6 mm x 15 cm | In distribution |
| 45-481530 | 15 mm x 30 cm | In distribution |
| 45-480420 | 4 mm x 20 cm | In distribution |
| 45-480410 | 4 mm x 10 cm | In distribution |
| 45-450405 | 4 mm x 5 cm | In distribution |
| 45-480405 | 4 mm x 5 cm | In distribution |
| 45-451020 | 10 mm x 20 cm | In distribution |
| 45-480310 | 3 mm x 10 cm | In distribution |
| 45-451230 | 12 mm x 30 cm | In distribution |
| 45-480415 | 4 mm x 15 cm | In distribution |
| 45-451215 | 12 mm x 15 cm | In distribution |
| 45-480202 | 2 mm x 2 cm | In distribution |
| 45-481530 | 15 mm x 30 cm | In distribution |
| 45-450620 | 6 mm x 20 cm | In distribution |
| 45-481010 | 10 mm x 10 cm | In distribution |
| 45-481015 | 10 mm x 15 cm | In distribution |
| 45-480415 | 4 mm x 15 cm | In distribution |
| 45-480405 | 4 mm x 5 cm | In distribution |
| 45-450610 | 6 mm x 10 cm | In distribution |
| 45-480310 | 3 mm x 10 cm | In distribution |
| 45-480204 | 2 mm x 4 cm | In distribution |
| 45-482030 | 20 mm x 30 cm | In distribution |
| 45-480505 | 5 mm x 5 cm | In distribution |
| 45-450515 | 5 mm x 15 cm | In distribution |
| 45-480820 | 8 mm x 20 cm | In distribution |
| 45-480815 | 8 mm x 15 cm | In distribution |
| 45-480302 | 3 mm x 2 cm | In distribution |
| 45-451530 | 15 mm x 30 cm | In distribution |
| 45-481220 | 12 mm x 20 cm | In distribution |
| 45-480305 | 3 mm x 5 cm | In distribution |
| 45-450615 | 6 mm x 15 cm | In distribution |
| 45-450410 | 4 mm x 10 cm | In distribution |
| 45-481215 | 12 mm x 15 cm | In distribution |
| 45-480620 | 6 mm x 20 cm | In distribution |
| 45-480510 | 5 mm x 10 cm | In distribution |
| 45-450820 | 8 mm x 20 cm | In distribution |
| 45-450815 | 8 mm x 15 cm | In distribution |
| 45-482030 | 20 mm x 30 cm | In distribution |
| 45-481220 | 12 mm x 20 cm | In distribution |
| 45-451015 | 10 mm x 15 cm | In distribution |
| 45-480420 | 4 mm x 20 cm | In distribution |
| 45-480520 | 5 mm x 20 cm | In distribution |
| 45-480515 | 5 mm x 15 cm | In distribution |
| 45-482020 | 20 mm x 20 cm | In distribution |
| 45-480615 | 6 mm x 15 cm | In distribution |
| 45-451520 | 15 mm x 20 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.