510(k) K202703

Vascutek Gelsoft Plus ERS Vascular Graft by Vascutek, Ltd. — Product Code DSY

K202703 is an FDA 510(k) premarket notification submitted by Vascutek, Ltd. for the device "Vascutek Gelsoft Plus ERS Vascular Graft". The FDA issued a decision of Substantially Equivalent on April 6, 2021. 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. Vascutek, Ltd. has at least 10 other 510(k) clearances on record.