REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER

REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K092361) manufactured by Invatec S.P.A.. 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 28, 2009. Regulation: 8.