510(k) K961999

SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS by Boston Scientific Scimed, Inc. — Product Code DYG

K961999 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS". The FDA issued a decision of Substantially Equivalent on November 19, 1996. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.