VariFuse Adjustable Infusion Catheter

VariFuse Adjustable Infusion Catheter is an FDA 510(k)-cleared medical device (K251318) manufactured by Argon Medical Devices, 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 January 19, 2026. Regulation: 8.