Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one…
Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for SET Rotarex®S 8F 110 cm (Straub Medical®) | Listed by | Straub Medical AG, Switzerland |
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Manufacturer |
| 510(k) | K172315 |
| Record published | 2020-01-31 |
| Record revised | 2025-09-22 (version 7) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter working length 110 cm; catheter gauge 8 Fr |
| Distribution end date | 2022-01-01 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
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.