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FDA 510(k)

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

K-Number: K213955 · 2022-07-16

ApplicantBecton, Dickinson and Company
Decision Date2022-07-16
Product CodeQTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub 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 2022-07-16 under 510(k) number K213955. The device is classified under product code QTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub is a medical device that received FDA 510(k) clearance on 2022-07-16. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K213955.

When did 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub receive FDA 510(k) clearance?

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub received FDA 510(k) clearance on 2022-07-16, under 510(k) number K213955.

Who is the listed applicant for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

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 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

The FDA product code for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub is QTI.

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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.

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