LUMA-CATH FIXED CURVE EP CATHETERS

LUMA-CATH FIXED CURVE EP CATHETERS is an FDA 510(k)-cleared medical device (K991025) 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 October 14, 1999. Regulation: 8.