ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is an FDA 510(k)-cleared medical device (K202218) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2020. Regulation: 8.