FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS is an FDA 510(k)-cleared medical device (K023162) manufactured by Fresenius Medical Care. 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 March 19, 2003. Regulation: 8.