RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN

RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN is an FDA 510(k)-cleared medical device (K120544) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 2012. Regulation: 8.