Coaxial Dilator Set (Micro-Introducer)

Coaxial Dilator Set (Micro-Introducer) is an FDA 510(k)-cleared medical device (K172487) manufactured by Galt Medical Corp.. 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 15, 2017. Regulation: 8.