BD ONECATH

About This 510(k) Submission

K042862 is an FDA 510(k) clearance for the BD ONECATH, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on December 3, 2004, 49 days after receiving the submission on October 15, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.