Cerepak Heliform
CEREPAK HELIFORM XtraSoft XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2 mm Coil Length - 6 cm
5manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
1recall
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 | Cerenovus, Inc., United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K220040 |
| Record published | 2022-09-15 |
| Record revised | 2024-05-10 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHD100250 | In distribution | |
| SHD180733 | In distribution | |
| SHD100258 | In distribution | |
| SHD182060 | In distribution | |
| SHD181040 | In distribution | |
| XHD100408 | In distribution | |
| SHD180520 | In distribution | |
| SHD100154 | In distribution | |
| XHD100254 | In distribution | |
| XHD100206 | In distribution | |
| SHD100308 | In distribution | |
| XHD100153 | In distribution | |
| SHD100925 | In distribution | |
| SHD181242 | In distribution | |
| XHD100152 | In distribution | |
| SHD100310 | In distribution | |
| XHE120206 | In distribution | |
| SHD100720 | In distribution | |
| SHD180625 | In distribution | |
| XHE120208 | In distribution | |
| XHD100203 | In distribution | |
| SHD180312 | In distribution | |
| SHD100410 | In distribution | |
| XHD100406 | In distribution | |
| SHD182460 | 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 |
|---|---|
| K262419 | 2026-08-14 |
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 |
|---|---|---|---|---|---|---|
| Cerenovus, Inc. | 510(k) number | 2025-10-02 | Class I | Under Investigation by firm | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. | 12004 |
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.