
Endocare, Inc.
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MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE is an FDA 510(k)-cleared medical device (K021010) manufactured by Endocare, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2002. Regulation: 8.