Cleared Traditional

BD Cathena? Safety IV Catheter

Jul 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K251155 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 July 11, 2025, 88 days after receiving the submission on April 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K251155 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2025
Decision Date July 11, 2025
Days to Decision 88 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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