DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER

DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER is an FDA 510(k)-cleared medical device (K973007) 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 November 5, 1997. Regulation: 8.