VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM

VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K982888) 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 October 19, 1998. Regulation: 8.