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Atrium Medical Corp.
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MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER is an FDA 510(k)-cleared medical device (K020634) 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 May 7, 2002. Regulation: 8.