Sensus Healthcare TVM Balloon Applicator

Sensus Healthcare TVM Balloon Applicator is an FDA 510(k)-cleared medical device (K190255) manufactured by Sensus Healthcare, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2019. Regulation: 8.