INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS is an FDA 510(k)-cleared medical device (K990800) manufactured by Intervascular, 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 January 7, 2001. Regulation: 8.