510(k) K202471

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft by Peca Labs — Product Code DSY

K202471 is an FDA 510(k) premarket notification submitted by Peca Labs for the device "exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft". The FDA issued a decision of Substantially Equivalent on December 11, 2020. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Peca Labs has at least 4 other 510(k) clearances on record.