REMOTE INTRODUCER, MODEL PI-1000

REMOTE INTRODUCER, MODEL PI-1000 is an FDA 510(k)-cleared medical device (K990907) manufactured by Image-Guided Neurologics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1999. Regulation: 8.