510(k) K162803

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts by Vascutek, Ltd. — Product Code DSY

K162803 is an FDA 510(k) premarket notification submitted by Vascutek, Ltd. for the device "Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts". The FDA issued a decision of Substantially Equivalent on July 14, 2017. 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.