IVT 0.014 PTFE-COATED TRACKWIRE

IVT 0.014 PTFE-COATED TRACKWIRE is an FDA 510(k)-cleared medical device (K971688) manufactured by Boston Scientific /International Technologies. 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 10, 1997. Regulation: 8.