Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is an FDA 510(k)-cleared medical device (K192996) manufactured by Biotronik, 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 November 20, 2019. Regulation: 8.