
Sulzer Intratherapeutics, Inc.
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INTRACOIL SELF-EXPANDING PERIPHERAL STENT is an FDA 510(k)-cleared medical device (K021563) manufactured by Sulzer Intratherapeutics, 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 May 30, 2002. Regulation: 8.