PLATINUM SERIES EP DIAGNOSTIC CATHETERS

PLATINUM SERIES EP DIAGNOSTIC CATHETERS is an FDA 510(k)-cleared medical device (K953185) manufactured by Medtronic Cardiorhythm. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1996. Regulation: 8.