EPTFE VASCULAR PROSTHESIS; SEALPTFE

EPTFE VASCULAR PROSTHESIS; SEALPTFE is an FDA 510(k)-cleared medical device (K030999) manufactured by Vascutek, Ltd.. 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 8, 2003. Regulation: 8.