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FDA 510(k) Applications Submitted by MARY 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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