FDA 510(k) Applications Submitted by MARY E DONLIN

FDA 510(k) Number Submission Date Device Name Applicant
K121451 05/16/2012 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE MEDTRONIC INC.
K070858 03/28/2007 EXPRESS SERIES MEDICAL GRAPHICS CORP.
K121767 06/15/2012 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE MEDTRONIC INC.
K122827 09/14/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 MEDTRONIC INC.
K122913 09/21/2012 AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 MEDTRONIC INC.
K093203 10/13/2009 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 MEDTRONIC INC.
K123314 10/25/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC.
K170951 03/31/2017 CardioCel 3D Admedus Regen Pty Ltd
K162579 09/15/2016 VascuCel Admedus Regen Pty Ltd


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