INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER

INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER is an FDA 510(k)-cleared medical device (K060757) manufactured by Irvine Biomedical, 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 18, 2006. Regulation: 8.