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Invatec Innovative Technologies, S.R.L.
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AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K042624) manufactured by Invatec Innovative Technologies, S.R.L.. 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 9, 2005. Regulation: 8.