510(k) K002007

SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS by Sulzer Carbomedics, Inc. — Product Code DSY

K002007 is an FDA 510(k) premarket notification submitted by Sulzer Carbomedics, Inc. for the device "SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 25, 2001. 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. Sulzer Carbomedics, Inc. has at least 7 other 510(k) clearances on record.