ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K924712) manufactured by Hearing Tech, 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 December 7, 1992. Regulation: 8.