THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER

THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER is an FDA 510(k)-cleared medical device (K134031) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 2014. Regulation: 8.