DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER is an FDA 510(k)-cleared medical device (K042016) manufactured by Datascope Corp.. 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 September 22, 2004. Regulation: 8.