Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is an FDA 510(k)-cleared medical device (K170474) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2017. Regulation: 8.