9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) is an FDA 510(k)-cleared medical device (K903344) manufactured by Kontron Instruments, 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 14, 1991. Regulation: 8.