Solitaire™ X
Stent SFR4-6-24-06 V03 SOLITIARE4
5manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K203358 |
| Record published | 2021-03-12 |
| Record revised | 2024-03-15 (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 |
| Sizes | Stent diameter 3 mm; stent length 20 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SFR4-3-40-10 | Stent Diameter 3.0 mm | In distribution |
| SFR4-6-40-10 | In distribution | |
| SFR4-6-24-06 | In distribution | |
| SFR4-4-40-10 | In distribution | |
| SFR4-4-20-10 | In distribution | |
| SFR4-6-40-10 | In distribution | |
| SFR4-3-20-10 | Stent Diameter 3.0 mm | In distribution |
| SFR4-4-20-05 | In distribution | |
| SFR4-4-20-05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
| Esperance | Shanghai Wallaby Medical Technologies Co., Inc. | 6 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
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.