FLO-RESTER(R) VESSEL SIZER

FLO-RESTER(R) VESSEL SIZER is an FDA 510(k)-cleared medical device (K905159) manufactured by Bio-Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1991. Regulation: 8.