510(k) K910154

USCI ILLUMEN-8 8F PTCA GUIDING CATHETER by C.R. Bard, Inc. — Product Code DOY

K910154 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "USCI ILLUMEN-8 8F PTCA GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code DOY (Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.