
Gish Biomedical, Inc.
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GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING is an FDA 510(k)-cleared medical device (K082082) 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.