Cleared Traditional

BD INTIMA II CLOSED IV CATHETER

Apr 2015
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K143610 is an FDA 510(k) clearance for the BD INTIMA II CLOSED IV CATHETER, 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 April 9, 2015, 111 days after receiving the submission on December 19, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K143610 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2014
Decision Date April 09, 2015
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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