VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY

VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY is an FDA 510(k)-cleared medical device (K910564) manufactured by Menlo Care, 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 May 5, 1991. Regulation: 8.