Cleared Traditional

AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED

K141019 · Fenwal, Inc. · Gastroenterology & Urology
Jun 2014
Decision
50d
Days
—
Risk

About This 510(k) Submission

K141019 is an FDA 510(k) clearance for the AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Fenwal, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on June 10, 2014, 50 days after receiving the submission on April 21, 2014. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K141019 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2014
Decision Date June 10, 2014
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class —

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