INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX is an FDA 510(k)-cleared medical device (K002847) manufactured by Maxxim Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 30, 2001. Regulation: 8.