NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K953608) manufactured by Meadox Medicals, Div. 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 19, 1995. Regulation: 8.