Attachable Cath Lab Hemostasis Valve

Attachable Cath Lab Hemostasis Valve is an FDA 510(k)-cleared medical device (K152528) 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 December 1, 2015. Regulation: 8.