AVE GL-1 GUIDING CATHETER

AVE GL-1 GUIDING CATHETER is an FDA 510(k)-cleared medical device (K984482) manufactured by Arterial Vascular Engineering Massachusetts, 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 29, 1999. Regulation: 8.