ENDOCATH ELECTROPHYSIOLOGY CATHETER

ENDOCATH ELECTROPHYSIOLOGY CATHETER is an FDA 510(k)-cleared medical device (K926549) manufactured by Endo-Therapeutics, 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 December 5, 1993. Regulation: 8.