R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM

R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K964538) 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 March 9, 1997. Regulation: 8.