POLYPLEX STIMULATING CATHETER SYSTEM

POLYPLEX STIMULATING CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K060186) manufactured by Te ME NA Sas. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2006. Regulation: 8.