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Bacchus Vascular, Inc.
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SPIRALFUSE PERIPHERAL INFUSION SYSTEM is an FDA 510(k)-cleared medical device (K082199) manufactured by Bacchus Vascular, 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 October 16, 2008. Regulation: 8.