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FDA 510(k)

FRESENIUS ART HEMOADSORPTION SYSTEM

K-Number: K050273 · 2005-06-08

ApplicantFresenius Medical Care North America
Decision Date2005-06-08
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

FRESENIUS ART HEMOADSORPTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2005-06-08 under 510(k) number K050273. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS ART HEMOADSORPTION SYSTEM?

FRESENIUS ART HEMOADSORPTION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-08. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K050273.

When did FRESENIUS ART HEMOADSORPTION SYSTEM receive FDA 510(k) clearance?

FRESENIUS ART HEMOADSORPTION SYSTEM received FDA 510(k) clearance on 2005-06-08, under 510(k) number K050273.

Who is the listed applicant for FRESENIUS ART HEMOADSORPTION SYSTEM?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRESENIUS ART HEMOADSORPTION SYSTEM?

The FDA product code for FRESENIUS ART HEMOADSORPTION SYSTEM is LKN.

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Other records listing Fresenius Medical Care North America as applicant

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.

K252181AquaAK162488Optiflux dialyzerK131611FRESENIUS DRY ACID DISSOLUTION UNITSK1240352008K@HOME HEMODIALYSIS MACHINEK121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMK121599CRIT-LINE CLIP (CLIC)

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Related Devices (Code: LKN)

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.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra Optia Apheresis SystemTerumobct, Inc.K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

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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