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FDA 510(k)

Microvolume Luer Access Device

K-Number: K212842 · 2022-01-18

ApplicantB.Braun Medical, Inc.
Decision Date2022-01-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Microvolume Luer Access Device is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K212842. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microvolume Luer Access Device?

Microvolume Luer Access Device is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K212842.

When did Microvolume Luer Access Device receive FDA 510(k) clearance?

Microvolume Luer Access Device received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212842.

Who is the listed applicant for Microvolume Luer Access Device?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microvolume Luer Access Device?

The FDA product code for Microvolume Luer Access Device is FPA.

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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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