Trufill DCS Orbit
TRUFILL DCS ORBIT Detachable Coil with Tight Distal Loop technology 175cm d= 2/3D D=4mm 10cm Coil Type: Mini Complex Fill
5manufacturers in China registered for this device type
74catalogue 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) | K123560 |
| Record published | 2015-09-20 |
| Record revised | 2023-09-15 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry; Special storage condition: Keep Away From Sunlight |
| Distribution end date | 2019-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 637MF3509 | Withdrawn | |
| 637MF2545 | Withdrawn | |
| 637HF0512 | Withdrawn | |
| 637CF0510 | Withdrawn | |
| 637HF0204 | Withdrawn | |
| 637HF0208 | Withdrawn | |
| 637CF0915 | Withdrawn | |
| 637MF0403 | Withdrawn | |
| 637HF1030 | Withdrawn | |
| 638CF0515 | Withdrawn | |
| 637HF0306 | Withdrawn | |
| 637CS1230 | Withdrawn | |
| 637HF0304 | Withdrawn | |
| 637HF0308 | Withdrawn | |
| 637CS1830 | Withdrawn | |
| 638MF0410 | Withdrawn | |
| 637CF0515 | Withdrawn | |
| 637MF0410 | Withdrawn | |
| 637MF0304 | Withdrawn | |
| 638CS0721 | Withdrawn | |
| 637CS0824 | Withdrawn | |
| 637HF1230 | Withdrawn | |
| 637CF1230 | Withdrawn | |
| 638CS0925 | Withdrawn | |
| 637CF0824 | Withdrawn | |
| 638CS0615 | Withdrawn | |
| 637HF0715 | Withdrawn | |
| 637MF0306 | Withdrawn | |
| 638CF0824 | Withdrawn | |
| 637CF0713 | Withdrawn | |
| 637CS1430 | Withdrawn | |
| 637HF0408 | Withdrawn | |
| 637HF0930 | Withdrawn | |
| 637CF0815 | Withdrawn | |
| 637CF0505 | Withdrawn | |
| 637MF0407 | Withdrawn | |
| 638CS2030 | Withdrawn | |
| 637HF0830 | Withdrawn | |
| 638CF0615 | Withdrawn | |
| 637CS2030 | Withdrawn | |
| 638CF0721 | Withdrawn | |
| 637HF0202 | Withdrawn | |
| 638CS1430 | Withdrawn | |
| 637CF1030 | Withdrawn | |
| 638CS1230 | Withdrawn | |
| 637CF0609 | Withdrawn | |
| 637HF0615 | Withdrawn | |
| 637MF3505 | Withdrawn | |
| 638CS1630 | Withdrawn | |
| 637CS0721 | Withdrawn | |
| 638CS0824 | Withdrawn | |
| 638CS1830 | Withdrawn | |
| 637MF3575 | Withdrawn | |
| 637CS1030 | Withdrawn | |
| 637MF2535 | Withdrawn | |
| 638CF0510 | Withdrawn | |
| 637MF0201 | Withdrawn | |
| 637HF0310 | Withdrawn | |
| 638CF1230 | Withdrawn | |
| 638CF0925 | Withdrawn | |
| 637MF0303 | Withdrawn | |
| 638CS1030 | Withdrawn | |
| 638MF0407 | Withdrawn | |
| 637CS0925 | Withdrawn | |
| 637CF0615 | Withdrawn | |
| 637CF0721 | Withdrawn | |
| 637CF0925 | Withdrawn | |
| 637HF0206 | Withdrawn | |
| 637CS0615 | Withdrawn | |
| 637MF0202 | Withdrawn | |
| 637HF0406 | Withdrawn | |
| 637MF2525 | Withdrawn | |
| 638CF1030 | Withdrawn | |
| 637CS1630 | Withdrawn |
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
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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.