REPROCESSED ELECTROPHYSIOLOGY CATHETERS

REPROCESSED ELECTROPHYSIOLOGY CATHETERS is an FDA 510(k)-cleared medical device (K061045) manufactured by Alliance Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2006. Regulation: 8.