SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060

SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 is an FDA 510(k)-cleared medical device (K060557) manufactured by Idev Technologies, 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 August 14, 2006. Regulation: 8.