510(k) K971339

INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS by Becton Dickinson Vascular Access, Inc. — Product Code FOZ

K971339 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS". The FDA issued a decision of Substantially Equivalent on December 24, 1997. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.