BALLOON TEMP. PACING CATHETER

BALLOON TEMP. PACING CATHETER is an FDA 510(k)-cleared medical device (K822003) manufactured by Ziehm International, 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 October 14, 1982. Regulation: 8.