
Gish Biomedical, Inc.
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SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING is an FDA 510(k)-cleared medical device (K024065) 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 March 4, 2003. Regulation: 8.