VASCULAR SOLUTIONS SCLERO-KIT

VASCULAR SOLUTIONS SCLERO-KIT is an FDA 510(k)-cleared medical device (K043019) manufactured by Vascular Solutions, 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 November 30, 2004. Regulation: 8.