510(k) K000743

BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 by Boston Scientific Scimed, Inc. — Product Code DQO

K000743 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020". The FDA issued a decision of Substantially Equivalent on September 6, 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.