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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 a medical device manufactured by Fresenius Kabi USA,Llc. It received FDA 510(k) clearance on 2018-12-04 under approval 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. It is manufactured by Fresenius Kabi USA,Llc. The 510(k) number is K180615.

When was AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter approved by the FDA?

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 approval number K180615.

What company makes 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 manufactured by Fresenius Kabi USA,Llc.

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.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING

Related PubMed Literature

PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023)

Other Devices by Fresenius Kabi USA,Llc

K162462AMICUS Separator System, AMICUS Separator System; Refurbished

Related Devices (Code: LKN)

K153601Spectra Optia Apheresis SystemTerumobct, Inc. K181049Spectra Optia Apheresis SystemTerumobct, Inc. K172590Spectra Optia Apheresis SystemTerumobct, Inc. K192150AMICUS Separator SystemFresenius Kabi AG K183081Spectra 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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