Bio Arterial Deluxe (IC-BAP-DX)

Bio Arterial Deluxe (IC-BAP-DX) is an FDA 510(k)-cleared medical device (K250974) manufactured by Bio Compression Systems, 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 December 11, 2025. Regulation: 8.