MODIFICATION TO SECURACATH, MODEL: SPK01

MODIFICATION TO SECURACATH, MODEL: SPK01 is an FDA 510(k)-cleared medical device (K083081) manufactured by Interrad Medical, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 2009. Regulation: 8.