
AngioDynamics, Inc.
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SPEEDLYSER INFUSION CATHETER KIT is an FDA 510(k)-cleared medical device (K033443) manufactured by AngioDynamics, 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 November 18, 2003. Regulation: 8.