FDA 510(k) Applications Submitted by Amy Stoklas-Oakes

FDA 510(k) Number Submission Date Device Name Applicant
K170311 02/01/2017 Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC.
K170474 02/16/2017 Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter Innovative Health, LLC.
K170922 03/29/2017 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) Innovative Health, LLC.
K171277 05/01/2017 Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC.
K171503 05/23/2017 Reprocessed CristaCath Diagnostic Electrophysiology Catheter Innovative Health, LLC.
K171788 06/15/2017 Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC.
K173262 10/11/2017 Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, Llc.


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