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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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