510(k) K863606

BUTTERFLY NON-CORING NEEDLE SET by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code FMI

K863606 is an FDA 510(k) premarket notification submitted by Cormed, Inc., Sub. C.R.Bard, Inc. for the device "BUTTERFLY NON-CORING NEEDLE SET". The FDA issued a decision of Substantially Equivalent on December 18, 1986. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Cormed, Inc., Sub. C.R.Bard, Inc. has at least 7 other 510(k) clearances on record.