MOZEC - RX PTCA BALLOON DILATATION CATHETER

MOZEC - RX PTCA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K131169) manufactured by Meril Life Sciences Private Limited. 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 23, 2013. Regulation: 8.