REPROCESSED ELECTROPHYSIOLOGY CATHETERS

REPROCESSED ELECTROPHYSIOLOGY CATHETERS is an FDA 510(k)-cleared medical device (K082023) manufactured by Ascent Healthcare Solutions. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 2008. Regulation: 8.