HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER is an FDA 510(k)-cleared medical device (K971504) manufactured by J-Lloyd Medical, Inc.. 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 19, 1998. Regulation: 8.