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FDA 510(k) Applications Submitted by Wendy Pinor
FDA 510(k) Number
Submission Date
Device Name
Applicant
K110450
02/16/2011
AGILIS NXT STEERABLE INTRODUCER
ST. JUDE MEDICAL
K101955
07/12/2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
ST. JUDE MEDICAL
K183490
12/17/2018
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
Medtronic Inc
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