ARRHYTHMIA MAPPING SYSTEM (8100/8300)

ARRHYTHMIA MAPPING SYSTEM (8100/8300) is an FDA 510(k)-cleared medical device (K965066) manufactured by Cardiac Pathways 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 10, 1997. Regulation: 8.