GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING

GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING is an FDA 510(k)-cleared medical device (K081947) manufactured by Gish Biomedical, 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 February 3, 2009. Regulation: 8.