Optima Coil System (OptiOne Coil System)
41 catalogue numbers from OPTIONE45L, listed by Balt USA, LLC, United States, under Device, Neurovascular Embolization. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
41catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls 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 | Balt USA, LLC, United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K252700 |
| Record published | 2026-01-28 |
| Record revised | 2026-02-06 (version 2) |
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 at a controlled room temperature in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPTIONE45L | 4.5mm x 16cm (Secondary Diameter x Length) | In distribution |
| OPTIONE55L | 5.5mm x 26cm (Secondary Diameter x Length) | In distribution |
| OPTIONE6XL | 6mm x 37cm (Implant Size) | In distribution |
| OPTIONE5L | 5mm x 20cm (Secondary Diameter x Length) | In distribution |
| OPTIONE55M | 5.5mm x 25cm (Implant Size) | In distribution |
| OPTIONE5S | 5mm x 16cm (Secondary Diameter x Length) | In distribution |
| OPTIONE6XL | 6mm x 37cm (Secondary Diameter x Length) | In distribution |
| OPTIONE3M | 3mm x 5.5cm (Secondary Diameter x Length) | In distribution |
| OPTIONE6L | 6mm x 34cm (Implant Size) | In distribution |
| OPTIONE4L | 4mm x 11cm (Implant Size) | In distribution |
| OPTIONE6S | 6mm x 28cm (Implant Size) | In distribution |
| OPTIONE4M | 4mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTIONE55XL | 5.5mm x 29cm (Implant Size) | In distribution |
| OPTIONE4M | 4mm x 10cm (Implant Size) | In distribution |
| OPTIONE5S | 5mm x 16cm (Implant Size) | In distribution |
| OPTIONE55S | 5.5mm x 22cm (Secondary Diameter x Length) | In distribution |
| OPTIONE45M | 4.5mm x 14.5cm (Secondary Diameter x Length) | In distribution |
| OPTIONE35L | 3.5mm x 10cm (Secondary Diameter x Length) | In distribution |
| OPTIONE3L | 3mm x 6cm (Secondary Diameter x Length) | In distribution |
| OPTIONE45S | 4.5mm x 13cm (Secondary Diameter x Length) | In distribution |
| OPTIONE4L | 4mm x 11cm (Secondary Diameter x Length) | In distribution |
| OPTIONE5L | 5mm x 20cm (Secondary Diameter x Length) | In distribution |
| OPTIONE35M | 3.5mm x 9cm (Secondary Diameter x Length) | In distribution |
| OPTIONE6L | 6mm x 34cm (Secondary Diameter x Length) | In distribution |
| OPTIONE4S | 4mm x 9cm (Implant Size) | In distribution |
| OPTIONE5M | 5mm x 18cm (Secondary Diameter x Length) | In distribution |
| OPTIONE45M | 4.5mm x 14.5cm (Implant Size) | In distribution |
| OPTIONE35S | 3.5mm x 8cm (Secondary Diameter x Length) | In distribution |
| OPTIONE6M | 6mm x 31cm (Secondary Diameter x Length) | In distribution |
| OPTIONE5M | 5mm x 18cm (Implant Size) | In distribution |
| OPTIONE6S | 6mm x 28cm (Secondary Diameter x Length) | In distribution |
| OPTIONE55XL | 5.5mm x 29cm (Secondary Diameter x Length) | In distribution |
| OPTIONE5XL | 5mm x 22cm (Secondary Diameter x Length) | In distribution |
| OPTIONE55S | 5.5mm x 22cm (Implant Size) | In distribution |
| OPTIONE5XL | 5mm x 22cm (Implant Size) | In distribution |
| OPTIONE6M | 6mm x 31cm (Implant Size) | In distribution |
| OPTIONE55M | 5.5mm x 25cm (Secondary Diameter x Length) | In distribution |
| OPTIONE45S | 4.5mm x 13cm (Implant Size) | In distribution |
| OPTIONE55L | 5.5mm x 26cm (Implant Size) | In distribution |
| OPTIONE4S | 4mm x 9cm (Secondary Diameter x Length) | In distribution |
| OPTIONE45L | 4.5mm x 16cm (Secondary Diameter x Length) | 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 |
|---|---|
| K254221 | 2026-01-27 |
| K252700 | 2025-09-26 |
| K242582 | 2024-09-27 |
| K223386 | 2022-12-06 |
| K200030 | 2020-02-01 |
Recalls
5 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 |
|---|---|---|---|---|
| 2025-05-08 | Class II | Vendor change control | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. | 2889 devices |
| 2024-01-03 | Class II | Material/Component Contamination | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the d | 31785 coils |
| 2022-09-07 | Class II | Error in labeling | Product pouch label does not match up with carton label | 41 impacted devices |
| 2022-07-26 | Class II | Under Investigation by firm | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. | 4 devices |
| 2022-01-04 | Class II | Process control | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting th | 51 devices |
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.