TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR

TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR is an FDA 510(k)-cleared medical device (K041006) manufactured by Kendall. 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 May 18, 2004. Regulation: 8.