
Interventional Thermodynamics, Inc.
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INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. is an FDA 510(k)-cleared medical device (K934377) manufactured by Interventional Thermodynamics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1994. Regulation: 8.