IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K961924) 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 10, 1997. Regulation: 8.