NOPROFILE OLBERT CATHETER SYSTEM

NOPROFILE OLBERT CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K944989) 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 April 25, 1995. Regulation: 8.