
Cryocath Technologies, Inc.
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FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 is an FDA 510(k)-cleared medical device (K081049) manufactured by Cryocath Technologies, 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 June 26, 2008. Regulation: 8.