WAVE Clinical Platform (2.0.000)

WAVE Clinical Platform (2.0.000) is an FDA 510(k)-cleared medical device (K250135) manufactured by Baxter Healthcare Corp/ Excel Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2026. Regulation: 8.