IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT is an FDA 510(k)-cleared medical device (K971192) manufactured by Impra, 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 April 14, 1997. Regulation: 8.