BIPOLAR TEMP. PACING CATHETER W/STYLETET

BIPOLAR TEMP. PACING CATHETER W/STYLETET is an FDA 510(k)-cleared medical device (K822002) 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.