
Datascope Corp.
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DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX is an FDA 510(k)-cleared medical device (K031569) 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 9, 2003. Regulation: 8.