PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT

PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT is an FDA 510(k)-cleared medical device (K905056) manufactured by Datascope 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 June 10, 1991. Regulation: 8.