FDA 510(k)

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

K-Number: K200891 · 2021-06-02

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 the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2021-06-02 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K200891.

When did BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System receive FDA 510(k) clearance?

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 510(k) number K200891.

Who is the listed applicant for BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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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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.