STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX

STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX is an FDA 510(k)-cleared medical device (K053116) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2005. Regulation: 8.