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FDA 510(k)

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

K-Number: K200891 · 2021-06-02

ApplicantBecton, Dickinson and Company
Decision Date2021-06-02
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2021-06-02 under approval number K200891. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System?

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System is a medical device that received FDA 510(k) clearance on 2021-06-02. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K200891.

When was BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System approved by the FDA?

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System received FDA 510(k) clearance on 2021-06-02, under approval number K200891.

What company makes BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System?

BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System?

The FDA product code for BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System is FOZ.

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Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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