510(k) K962433

MEADOX EXXCEL EPTFE VASCULAR GRAFT by Meadox Medicals, Div. Boston Scientific Corp. — Product Code DSY

K962433 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "MEADOX EXXCEL EPTFE VASCULAR GRAFT". The FDA issued a decision of ST on March 17, 1997. 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. Meadox Medicals, Div. Boston Scientific Corp. has at least 10 other 510(k) clearances on record.