510(k) K021735

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER by Boston Scientific Scimed, Inc. — Product Code DQY

K021735 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on August 8, 2002. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.