ACS ANGIOSCOPE GUIDE WIRE

ACS ANGIOSCOPE GUIDE WIRE is an FDA 510(k)-cleared medical device (K883000) manufactured by Advanced Cardiovascular Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 1988. Regulation: 8.