FDA 510(k) Applications for Medical Device Product Code "MVR"
(Device,Anastomotic,Microvascular)

FDA 510(k) Number Applicant Device Name Decision Date
K190499 Baxter/ Synovis Micro Companies Alliance Inc. Gem FlowCoupler System 09/06/2019
K191252 Baxter/ Synovis Micro Companies Alliance Inc. Gem FlowCoupler System 07/09/2019
K142309 Synovis Life Technologies, Inc. GEM Flow COUPLER Device and System 09/16/2014
K143589 Synovis Life Technologies, Inc. GEM Flow COUPLER Device and System 01/16/2015
K132727 SYNOVIS LIFE TECHNOLOGIES, INC. GEM FLOW COUPLER DEVICE AND SYSTEM 10/22/2013
K093310 SYNOVIS MICRO COMPANIES ALLIANCE, INC. GEM FLOW COUPLER DEVICE AND SYSTEM 02/01/2010
K040163 SYNOVIS MICRO COMPANIES ALLIANCE, INC. MICROVASCULAR ANASTOMOTIC DEVICE 04/16/2004
K090679 VIOPTIX, INC. VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM 04/17/2009


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