SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH

SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH is an FDA 510(k)-cleared medical device (K902587) 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 December 2, 1990. Regulation: 8.