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FDA 510(k)

AMICUS Separator System, AMICUS Separator System; Refurbished

K-Number: K162462 · 2016-11-23

ApplicantFresenius Kabi USA,Llc
Decision Date2016-11-23
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMICUS Separator System, AMICUS Separator System; Refurbished 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 2016-11-23 under 510(k) number K162462. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICUS Separator System, AMICUS Separator System; Refurbished?

AMICUS Separator System, AMICUS Separator System; Refurbished is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Fresenius Kabi USA,Llc. The 510(k) number is K162462.

When did AMICUS Separator System, AMICUS Separator System; Refurbished receive FDA 510(k) clearance?

AMICUS Separator System, AMICUS Separator System; Refurbished received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162462.

Who is the listed applicant for AMICUS Separator System, AMICUS Separator System; Refurbished?

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 Separator System; Refurbished?

The FDA product code for AMICUS Separator System, AMICUS Separator System; Refurbished is GKT.

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.

K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

Related Devices (Code: GKT)

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.

K200530AMICUS Separator SystemFresenius Kabi AG

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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