6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX

6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX is an FDA 510(k)-cleared medical device (K011734) manufactured by Mogul Enterprises. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2001. Regulation: 8.