MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K050073) manufactured by Invatec Innovative Technologies, S.R.L.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2005. Regulation: 8.