EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 is an FDA 510(k)-cleared medical device (K033050) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2004. Regulation: 8.