SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX

SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX is an FDA 510(k)-cleared medical device (K993698) manufactured by Mogul Enterprises. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 15, 2000. Regulation: 8.