DATASCOPE SLIDEWIRE(TM)

DATASCOPE SLIDEWIRE(TM) is an FDA 510(k)-cleared medical device (K901347) 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 20, 1990. Regulation: 8.