ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT is an FDA 510(k)-cleared medical device (K946029) manufactured by Advanced Cardiovascular Systems, 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 February 23, 1995. Regulation: 8.