MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS is an FDA 510(k)-cleared medical device (K901018) 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 May 29, 1990. Regulation: 8.