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Invatec Innovative Technologies
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SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX is an FDA 510(k)-cleared medical device (K042537) manufactured by Invatec Innovative Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2004. Regulation: 8.