INTRODUCER SET, MODEL ADELANTE-S SERIES

INTRODUCER SET, MODEL ADELANTE-S SERIES is an FDA 510(k)-cleared medical device (K122084) 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 August 28, 2012. Regulation: 8.