4F STERILE BALLOON-LESS, CATHETER 913-28

4F STERILE BALLOON-LESS, CATHETER 913-28 is an FDA 510(k)-cleared medical device (K791026) manufactured by Waters Assoc., Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1979. Regulation: 8.