The p48 MW and p64 MW devices, or HPC technology are not approved for sale, nor are available for sale or use in the United States.
The pRESET Thrombectomy Device, and pRESET LUX Thrombectomy Device are not approved for sale, nor are they available for sale or use in the United States. The pRESET Thrombectomy device is available for use in the approved IDE; PROST Randomized Control Trial (ref. NCT03994822).
