Verge Medical, Inc. · Class II · Cleared Jan 21, 2026
| K-number | K253730 |
| Device name | RoVo Mechanical Thrombectomy System |
| Applicant | Verge Medical, Inc. |
| Product code | QEW |
| Device class | Class II |
| Decision date | Jan 21, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The RoVo Mechanical Thrombectomy System is a single-use sterile device indicated for removing soft emboli and thrombi from peripheral blood vessels. It consists of a handheld driver, a locking aspiration syringe, and a catheter that rotates when the operator squeezes the trigger, while aspiration occurs independently when the stopcock opens to vacuum.
The subject device uses the same RoVo Driver and RoVo Locking Aspiration Syringe as the predicate, but incorporates a different commercially available off-the-shelf catheter model (6F, 100cm, up to 0.038" guidewire compatible) that is privately labeled by the original manufacturer. All other system characteristics, materials, sterilization method (ethylene oxide), shelf life (12 months), and dimensions remain the same.
Not stated in this summary.
The subject device is substantially equivalent to the predicate RoVo System (K220780) based on identical indications for use, same fundamental operating principles, same classification and regulatory code, and identical system components except for the catheter model. Bench testing confirmed the new catheter meets all pre-defined acceptance criteria for shelf life, trackability, torque transmission, kink resistance, air leak resistance, tensile strength, and simulated use. The original catheter manufacturer's biocompatibility, packaging, and sterilization data further support substantial equivalence.
View the full FDA submission: accessdata.fda.gov