GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT is an FDA 510(k)-cleared medical device (K983927) manufactured by Arterial Vascular Engineering, 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 March 10, 1999. Regulation: 8.