STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER

STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K132430) 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 October 16, 2013. Regulation: 8.