JETi Hydrodynamic Thrombectomy System

JETi Hydrodynamic Thrombectomy System is an FDA 510(k)-cleared medical device (K243549) manufactured by ABBOTT MEDICAL. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2025. Regulation: 8.