STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO

STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO is an FDA 510(k)-cleared medical device (K093720) 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 22, 2009. Regulation: 8.