GELBFISH FLEX VASCULAR DILATOR

GELBFISH FLEX VASCULAR DILATOR is an FDA 510(k)-cleared medical device (K030260) manufactured by Vascumetrix, LLC. 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 19, 2003. Regulation: 8.