HydroCoil Helical
69 catalogue numbers from 181415HES-V, listed by MicroVention, Inc., United States, under Device, Neurovascular Embolization. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
69catalogue numbers in this listing
32510(k) clearances naming this product code
16recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | MicroVention, Inc., United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2018-08-07 |
| Record revised | 2026-04-28 (version 6) |
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 |
|---|---|---|
| 181415HES-V | 14 mm x 15 cm | In distribution |
| 100306HES-V | 3 mm x 6 cm | In distribution |
| 140615HES-V | 6 mm x 15 cm | In distribution |
| 100506HES-V | 5 mm x 6 cm | In distribution |
| 100304HES-V | 3 mm x 4 cm | In distribution |
| 181015HES-V | 10 mm x 15 cm | In distribution |
| 140203HES-V | 2 mm x 3 cm | In distribution |
| 180810HES-V | 8 mm x 10 cm | In distribution |
| 140915HES-V | 9 mm x 15 cm | In distribution |
| 100302HES-V | 3 mm x 2 cm | In distribution |
| 140610HES-V | 6 mm x 10 cm | In distribution |
| 140303HES-V | 3 mm x 3 cm | In distribution |
| 140815HES-V | 8 mm x 15 cm | In distribution |
| 140630HES-V | 6 mm x 30 cm | In distribution |
| 140820HES-V | 8 mm x 20 cm | In distribution |
| 140205HES-V | 2 mm x 5 cm | In distribution |
| 182015HES-V | 20 mm x 15 cm | In distribution |
| 100606HES-V | 6 mm x 6 cm | In distribution |
| 140720HES-V | 7 mm x 20 cm | In distribution |
| 140910HES-V | 9 mm x 10 cm | In distribution |
| 140510HES-V | 5 mm x 10 cm | In distribution |
| 100610HES-V | 6 mm x 10 cm | In distribution |
| 180820HES-V | 8 mm x 20 cm | In distribution |
| 181215HES-V | 12 mm x 15 cm | In distribution |
| 100508HES-V | 5 mm x 8 cm | In distribution |
| 100608HES-V | 6 mm x 8 cm | In distribution |
| 181615HES-V | 16 mm x 15 cm | In distribution |
| 181815HES-V | 18 mm x 15 cm | In distribution |
| 140515HES-V | 5 mm x 15 cm | In distribution |
| 140930HES-V | 9 mm x 30 cm | In distribution |
| 180815HES-V | 8 mm x 15 cm | In distribution |
| 181420HES-V | 14 mm x 20 cm | In distribution |
| 140715HES-V | 7 mm x 15 cm | In distribution |
| 140830HES-V | 8 mm x 30 cm | In distribution |
| 140620HES-V | 6 mm x 20 cm | In distribution |
| 140305HES-V | 3 mm x 5 cm | In distribution |
| 180610HES-V | 6 mm x 10 cm | In distribution |
| 180920HES-V | 9 mm x 20 cm | In distribution |
| 140730HES-V | 7 mm x 30 cm | In distribution |
| 140710HES-V | 7 mm x 10 cm | In distribution |
| 140407HES-V | 4 mm x 7 cm | In distribution |
| 141030HES-V | 10 mm x 30 cm | In distribution |
| 100504HES-V | 5 mm x 4 cm | In distribution |
| 140307HES-V | 3 mm x 7 cm | In distribution |
| 100308HES-V | 3 mm x 8 cm | In distribution |
| 181020HES-V | 10 mm x 20 cm | In distribution |
| 140410HES-V | 4 mm x 10 cm | In distribution |
| 140920HES-V | 9 mm x 20 cm | In distribution |
| 100410HES-V | 4 mm x 10 cm | In distribution |
| 140405HES-V | 4 mm x 5 cm | In distribution |
| 100406HES-V | 4 mm x 6 cm | In distribution |
| 181820HES-V | 18 mm x 20 cm | In distribution |
| 100408HES-V | 4 mm x 8 cm | In distribution |
| 180915HES-V | 9 mm x 15 cm | In distribution |
| 140810HES-V | 8 mm x 10 cm | In distribution |
| 100206HES-V | 2 mm x 6 cm | In distribution |
| 182020HES-V | 20 mm x 20 cm | In distribution |
| 181010HES-V | 10 mm x 10 cm | In distribution |
| 141010HES-V | 10 mm x 10 cm | In distribution |
| 180910HES-V | 9 mm x 10 cm | In distribution |
| 181220HES-V | 12 mm x 20 cm | In distribution |
| 141020HES-V | 10 mm x 20 cm | In distribution |
| 100202HES-V | 2 mm x 2 cm | In distribution |
| 100510HES-V | 5 mm x 10 cm | In distribution |
| 100204HES-V | 2 mm x 4 cm | In distribution |
| 141015HES-V | 10 mm x 15 cm | In distribution |
| 181620HES-V | 16 mm x 20 cm | In distribution |
| 180710HES-V | 7 mm x 10 cm | In distribution |
| 100404HES-V | 4 mm x 4 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162999 | 2017-03-29 |
| K161367 | 2016-08-31 |
| K161452 | 2016-08-31 |
| K153594 | 2016-01-22 |
| K132952 | 2013-12-19 |
| K131948 | 2013-10-04 |
| K132317 | 2013-09-20 |
| K120908 | 2012-04-25 |
| K113457 | 2011-12-16 |
| K112181 | 2011-12-01 |
| K112226 | 2011-09-29 |
| K111451 | 2011-09-20 |
| K103758 | 2011-04-28 |
| K100454 | 2010-04-22 |
| K093919 | 2010-01-21 |
| K093358 | 2010-01-15 |
| K091641 | 2009-06-30 |
| K090891 | 2009-06-22 |
| K090357 | 2009-04-10 |
| K090168 | 2009-03-12 |
| K090001 | 2009-03-05 |
| K082461 | 2008-10-02 |
| K080666 | 2008-07-11 |
| K070656 | 2007-06-15 |
| K050954 | 2005-06-28 |
| K041551 | 2004-07-07 |
| K033836 | 2003-12-30 |
| K032590 | 2003-10-22 |
| K022735 | 2002-09-06 |
| K020434 | 2002-07-29 |
| K021914 | 2002-07-09 |
| K012145 | 2001-10-29 |
Recalls
16 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 |
|---|---|---|---|---|---|
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 847 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 1,725 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 3,442 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 32 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 780 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 9 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 19 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 403 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 486 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 5,777 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 666 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 169 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 991 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 85 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 2,762 units | 2022-01-26 |
| 2019-11-22 | Class II | Process design | The devices may be missing the implant coil. | 409 units | 2022-01-26 |
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.