Hilal
The Hilal Embolization MicroCoils are small coils intended for arterial and venous embolization in the peripheral vasculature. The FDA filing names Hilal as the trade device and describes…
The Hilal Embolization MicroCoils are small coils intended for arterial and venous embolization in the peripheral vasculature. The FDA filing names Hilal as the trade device and describes the coil system.
The filing describes platinum wire coils with nylon fibers in straight, single-curl and multiple-curl forms. It says they are delivered through microcatheters and loaded into a delivery catheter using a loading cartridge and stylet.
Listed Item
Hilal Embolization Microcoil
Coil Dimensions
The listed coil lengths range from 0.5 to 6.0 centimeters, with coiled embolus diameters from 2 to 10 millimeters. The filing describes a pushable coil delivered with a wire guide through a delivery catheter.
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K160219 |
| Record published | 2018-09-04 |
| Record revised | 2021-02-05 (version 3) |
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: Store in dark, dry, cool place. |
| Distribution end date | 2020-06-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G47498 | In distribution | |
| G47499 | In distribution | |
| G47514 | Withdrawn | |
| G47512 | Withdrawn | |
| G47503 | Withdrawn | |
| G47511 | Withdrawn | |
| G47508 | Withdrawn | |
| G47510 | Withdrawn | |
| G47501 | Withdrawn | |
| G47516 | Withdrawn | |
| G47509 | Withdrawn | |
| G47506 | Withdrawn | |
| G47504 | Withdrawn | |
| G47507 | Withdrawn | |
| G47502 | Withdrawn | |
| G47513 | Withdrawn | |
| G47500 | Withdrawn | |
| G47515 | Withdrawn | |
| G47505 | Withdrawn |
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 |
|---|---|
| K160219 | 2016-08-03 |
| K153778 | 2016-05-19 |
| K150931 | 2015-12-18 |
| K150964 | 2015-12-18 |
| K151676 | 2015-07-22 |
| K123712 | 2013-01-03 |
| K090624 | 2009-04-02 |
| K063619 | 2006-12-20 |
| K052834 | 2005-11-23 |
| K993455 | 2000-01-11 |
| K992121 | 1999-12-20 |
| K940189 | 1994-11-28 |
| K940982 | 1994-10-14 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cook Incorporated | 510(k) number | 2022-05-05 | Class II | Under Investigation by firm | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 106,033 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-04-17 | Class II | Process control | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. | 2952 units | |
| 2022-05-05 | Class II | Under Investigation by firm | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 106,033 | |
| 2022-05-05 | Class II | Under Investigation by firm | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 106,033 | |
| 2005-09-26 | Not classified | Other | The coil is 20 centimeters in length, but the label states the length is 20 millimeters. | 242 | 2006-01-10 |
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.