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Tayside Flow Technologies Limited
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EPTFE SLFTM SPIRAL VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K083169) manufactured by Tayside Flow Technologies Limited. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2009. Regulation: 8.