VAXCEL PORT, MODELS 45-336 AND 45-338

VAXCEL PORT, MODELS 45-336 AND 45-338 is an FDA 510(k)-cleared medical device (K032375) manufactured by Boston Scientific Corp. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 2003. Regulation: 8.