FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH is an FDA 510(k)-cleared medical device (K050889) manufactured by Crs Medical Diagnostics, 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 August 25, 2005. Regulation: 8.