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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 a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-07-16 under approval 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. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K213955.

When was 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub approved by the FDA?

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

What company makes 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub is manufactured by Becton, Dickinson and Company.

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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