
Thermopeutix, Inc.
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DUFLO CATHETER (HEPARIN COATED) is an FDA 510(k)-cleared medical device (K093847) manufactured by Thermopeutix, 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 August 24, 2010. Regulation: 8.