Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is an FDA 510(k)-cleared medical device (K221041) manufactured by Shockwave Medical, Inc.. 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 24, 2022. Regulation: 8.