510(k) K013304

BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code DBY

K013304 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER". The FDA issued a decision of Substantially Equivalent on January 2, 2002. The device falls under product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.