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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 a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2022-01-18 under approval 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. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K212842.

When was Microvolume Luer Access Device approved by the FDA?

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

What company makes Microvolume Luer Access Device?

Microvolume Luer Access Device is manufactured by B.Braun Medical, Inc..

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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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41613088 Orphan medical devices: addressing the regulatory and access gaps in the EU and US. Frontiers in public health (2025) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

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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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