SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER

SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER is an FDA 510(k)-cleared medical device (K902091) manufactured by Schneider Intl., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 1990. Regulation: 8.