UNICATH SP BI-PLANE (MODEL M269 & M289)

UNICATH SP BI-PLANE (MODEL M269 & M289) is an FDA 510(k)-cleared medical device (K973744) manufactured by Xre 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 December 28, 1997. Regulation: 8.