LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING

LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING is an FDA 510(k)-cleared medical device (K053589) manufactured by Bard Access Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2006. Regulation: 8.