SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER

SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER is an FDA 510(k)-cleared medical device (K950047) manufactured by Isomedix Operations, 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 April 4, 1995. Regulation: 8.