Solitaire™
Stent SFR3-6-24-06 V05 Extended IFU
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | POL |
| Device type | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5600 |
| 510(k) | K160641 |
| Record published | 2018-12-09 |
| Record revised | 2026-06-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store in a dry cool place |
| Distribution end date | 2026-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SFR3-6-24-06 | In distribution | |
| SFR3-6-24-06 | Withdrawn | |
| SFR3-6-40-10 | Withdrawn | |
| SFR3-4-20-05 | Withdrawn | |
| SFR3-6-20-10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 11 |
| Solitaire ™ Platinum | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 5 |
| pRESET® Lite Thrombectomy Device (4mm x 20mm) | Phenox Limited | 1 |
| Trevo NXT | Stryker GmbH | 1 |
| pRESET® Lite Thrombectomy Device (3mm x 20mm) | Phenox Limited | 1 |
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.