MEDI-DYNE GUIDING CATHETER

MEDI-DYNE GUIDING CATHETER is an FDA 510(k)-cleared medical device (K970401) manufactured by Medi-Dyne, 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 31, 1997. Regulation: 8.