MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)

MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) is an FDA 510(k)-cleared medical device (K921706) 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 May 19, 1993. Regulation: 8.