FDA 510(k) Applications Submitted by Adam Bakken

FDA 510(k) Number Submission Date Device Name Applicant
K251211 04/18/2025 ViewFlexÖ Xtra ICE Catheter; ViewFlexÖ Eco Reprocessed ICE Catheter; AdvisorÖ HD Grid Mapping Catheter, Sensor EnabledÖ; AdvisorÖ HD Grid X Mapping Catheter, Sensor EnabledÖ; AgilisÖ NxT Steerable Introducer; AgilisÖ NxT Steerable Introducer Dual-ReachÖ Abbott Medical


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