ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW

ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW is an FDA 510(k)-cleared medical device (K881897) 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 August 2, 1988. Regulation: 8.