Cleared Special

BD Cathena Safety IV Catheter

Sep 2020
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K201717 is an FDA 510(k) clearance for the BD Cathena Safety 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 September 22, 2020, 91 days after receiving the submission on June 23, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K201717 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2020
Decision Date September 22, 2020
Days to Decision 91 days
Submission Type Special
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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