510(k) K233783

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts by Peca Labs, Inc. — Product Code DSY

K233783 is an FDA 510(k) premarket notification submitted by Peca Labs, Inc. for the device "exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts". The FDA issued a decision of Substantially Equivalent on January 17, 2024. 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, Inc. has at least 4 other 510(k) clearances on record.