FDA 510(k) Applications Submitted by Kim Forch

FDA 510(k) Number Submission Date Device Name Applicant
K200530 03/02/2020 AMICUS Separator System Fresenius Kabi AG
K180615 03/08/2018 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter Fresenius Kabi USA LLC
K141019 04/21/2014 AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED FENWAL, INC.
K111702 06/17/2011 AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC.
K162462 09/02/2016 AMICUS Separator System, AMICUS Separator System; Refurbished FRESENIUS KABI USA LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact