SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS is an FDA 510(k)-cleared medical device (K990503) 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 December 8, 1999. Regulation: 8.