Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is an FDA 510(k)-cleared medical device (K162181) manufactured by Cardiacassist, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2017. Regulation: 8.