ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER is an FDA 510(k)-cleared medical device (K960479) manufactured by Arrow Intl., 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 16, 1996. Regulation: 8.