SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS is an FDA 510(k)-cleared medical device (K993667) manufactured by Sulzermedica. 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 27, 2000. Regulation: 8.