X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS

X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS is an FDA 510(k)-cleared medical device (K083301) manufactured by Terumo Cardiovascular Systems Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2008. Regulation: 8.