510(k) K000956

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS by Boston Scientific Scimed, Inc. — Product Code DQO

K000956 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS". The FDA issued a decision of Substantially Equivalent on April 21, 2000. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.