Solitaire™ X-Pack
KIT XPACK346 V01 US
2manufacturers in China registered for this device type
11catalogue 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) | K180959 |
| Record published | 2019-11-07 |
| Record revised | 2026-06-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2026-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XPACK346 | In distribution | |
| XPACK347 | In distribution | |
| XPACK214 | Withdrawn | |
| XPACK320 | Withdrawn | |
| XPACK201 | Withdrawn | |
| XPACK339 | Withdrawn | |
| XPACK301 | Withdrawn | |
| XPACK217 | Withdrawn | |
| XPACK313 | Withdrawn | |
| XPACK306 | Withdrawn | |
| XPACK343 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Solitaire ™ Platinum | Micro Therapeutics, Inc. | 9 |
| Solitaire™ | Micro Therapeutics, Inc. | 5 |
| 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.