ATRAC TM MULTIPURPOSE BALLOON CATHETER

ATRAC TM MULTIPURPOSE BALLOON CATHETER is an FDA 510(k)-cleared medical device (K820646) manufactured by Atrium Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 1982. Regulation: 8.