
Boston Scientific/Medi-Tech
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MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER is an FDA 510(k)-cleared medical device (K020012) manufactured by Boston Scientific/Medi-Tech. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2002. Regulation: 8.