INTRODUCER SETS, MODEL ADELANTE RADIAL

INTRODUCER SETS, MODEL ADELANTE RADIAL is an FDA 510(k)-cleared medical device (K130633) manufactured by Oscor, 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 February 12, 2014. Regulation: 8.