Medical Device Manufacturer · US , Scottsdale , AZ

Innovative Health, LLC - FDA 510(k) Cleared Devices

48 submissions · 48 cleared · Since 2016
48
Total
48
Cleared
0
Denied
48 devices
26-48 of 48
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Cardiovascular · 122d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Cardiovascular · 145d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Cardiovascular · 121d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Cardiovascular · 92d
Cleared Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · OWQ
Cardiovascular · 146d
Cleared Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · NLH
Cardiovascular · 141d
Cleared Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K171277 · DRF
Cardiovascular · 175d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Cardiovascular · 135d
Cleared Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · OWQ
Cardiovascular · 205d
Cleared Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K170922 · NLH
Cardiovascular · 85d
Cleared Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · OWQ
Cardiovascular · 120d
Cleared Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
K170311 · PNE
Cardiovascular · 121d
Cleared Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · NLH
Cardiovascular · 133d
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Cardiovascular · 156d
Cleared Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
K161769 · DRF
Cardiovascular · 161d
Cleared Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
K160421 · NLH
Cardiovascular · 260d
Cleared Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · NLH
Cardiovascular · 160d
Cleared Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · NLH
Cardiovascular · 127d
Cleared Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · NLH
Cardiovascular · 109d
Cleared May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
K160242 · NLH
Cardiovascular · 99d
Cleared May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · NLH
Cardiovascular · 96d
Cleared Mar 14, 2016
Reprocessed Electrophysiology Catheter
K153153 · NLH
Cardiovascular · 133d
Cleared Mar 10, 2016
Reprocessed Diagnostic Ultrasound Catheter
K153090 · OWQ
Cardiovascular · 136d
Filters
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