ORTHOGONAL EP CATHETERS

ORTHOGONAL EP CATHETERS is an FDA 510(k)-cleared medical device (K990958) 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 June 2, 1999. Regulation: 8.