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FDA 510(k)

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

K-Number: K180615 · 2018-12-04

ApplicantFresenius Kabi USA,Llc
Decision Date2018-12-04
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi USA,Llc. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K180615. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter?

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Fresenius Kabi USA,Llc. The 510(k) number is K180615.

When did AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter receive FDA 510(k) clearance?

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter received FDA 510(k) clearance on 2018-12-04, under 510(k) number K180615.

Who is the listed applicant for AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter?

The FDA 510(k) record lists Fresenius Kabi USA,Llc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter?

The FDA product code for AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter is LKN.

Other records listing Fresenius Kabi USA,Llc 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.

K162462AMICUS Separator System, AMICUS Separator System; Refurbished

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.K181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

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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