SUB-4(TM), PERIPHERAL DILATATION CATHETER

SUB-4(TM), PERIPHERAL DILATATION CATHETER is an FDA 510(k)-cleared medical device (K913689) 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 15, 1991. Regulation: 8.