LUMA-CATH STEERABLE EP CATHETERS

LUMA-CATH STEERABLE EP CATHETERS is an FDA 510(k)-cleared medical device (K991878) 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 December 9, 1999. Regulation: 8.