IRIDIUM 192 WIRES

IRIDIUM 192 WIRES is an FDA 510(k)-cleared medical device (K850163) manufactured by Syncor Intl. Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 1985. Regulation: 8.