GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER is an FDA 510(k)-cleared medical device (K990753) manufactured by Cook, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 1999. Regulation: 8.