NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER

NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER is an FDA 510(k)-cleared medical device (K090918) manufactured by Nfocus Neuromedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2009. Regulation: 8.