BAXTER HEMOSTASIS VALVE INTRODUCERS

BAXTER HEMOSTASIS VALVE INTRODUCERS is an FDA 510(k)-cleared medical device (K981909) manufactured by Baxter Edwards. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1998. Regulation: 8.