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FDA 510(k)

FlowArt® Needle-Free Split Septum Valve

K-Number: K222889 · 2023-01-20

ApplicantAsset Medikal Tasarim San Tic As.
Decision Date2023-01-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FlowArt® Needle-Free Split Septum Valve is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal Tasarim San Tic As.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222889. 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 FlowArt® Needle-Free Split Septum Valve?

FlowArt® Needle-Free Split Septum Valve is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Asset Medikal Tasarim San Tic As.. The 510(k) number is K222889.

When did FlowArt® Needle-Free Split Septum Valve receive FDA 510(k) clearance?

FlowArt® Needle-Free Split Septum Valve received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222889.

Who is the listed applicant for FlowArt® Needle-Free Split Septum Valve?

The FDA 510(k) record lists Asset Medikal Tasarim San Tic As. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlowArt® Needle-Free Split Septum Valve?

The FDA product code for FlowArt® Needle-Free Split Septum Valve is FPA.

Related Clinical Trials

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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