FDA 510(k) Applications Submitted by Innovative Health, Llc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190127 |
01/28/2019 |
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K180710 |
03/19/2018 |
Reprocessed DecaNav Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K190785 |
03/27/2019 |
Reprocessed PentaRay Nav eco High-Density Mapping Catheter |
Innovative Health, LLC. |
| K190980 |
04/15/2019 |
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter |
Innovative Health, LLC. |
| K191170 |
05/01/2019 |
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter |
Innovative Health, LLC. |
| K181458 |
06/04/2018 |
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter |
Innovative Health, LLC. |
| K181618 |
06/19/2018 |
Reprocessed Torqr Diagnostic EP Catheter |
Innovative Health, LLC. |
| K191880 |
07/15/2019 |
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K181897 |
07/16/2018 |
Reprocessed Marinr Diagnostic EP Catheter |
Innovative Health, LLC. |
| K182386 |
09/04/2018 |
Reprocessed Supreme Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K182488 |
09/11/2018 |
Reprocessed Response Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
| K192998 |
10/28/2019 |
Reprocessed BRK Transseptal Needle |
Innovative Health, LLC. |
| 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. |
| K160303 |
02/04/2016 |
Reprocessed Polaris X Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K160421 |
02/16/2016 |
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K160496 |
02/22/2016 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K161393 |
05/19/2016 |
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K163560 |
12/19/2016 |
Reprocessed AcuNav Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
| K200060 |
01/13/2020 |
Reprocessed NRG Transseptal Needle |
Innovative Health, LLC. |
| K200212 |
01/28/2020 |
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
Innovative Health, LLC. |
| K230376 |
02/13/2023 |
Reprocessed Agilis NxT Steerable Introducer |
Innovative Health, LLC. |
| K210655 |
03/04/2021 |
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
Innovative Health, LLC. |
| K231015 |
04/10/2023 |
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters |
Innovative Health, LLC. |
| K211276 |
04/27/2021 |
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
| K211662 |
06/01/2021 |
Reprocessed IntellaMap Orion High Resolution Mapping Catheter |
Innovative Health, LLC. |
| K221854 |
06/27/2022 |
Reprocesses Umbilical Cable |
Innovative Health, LLC. |
| K232037 |
07/10/2023 |
Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath |
Innovative Health, LLC. |
| K212165 |
07/12/2021 |
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath |
Innovative Health, LLC. |
| K202042 |
07/23/2020 |
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
| K212776 |
09/01/2021 |
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
Innovative Health, LLC. |
| K203261 |
11/05/2020 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K213584 |
11/12/2021 |
Reprocessed NRG Transseptal Needle |
Innovative Health, LLC. |
| K193263 |
11/26/2019 |
Reprocessed Achieve Catheter Connecting Cable |
Innovative Health, LLC. |
| K203655 |
12/15/2020 |
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) |
Innovative Health, LLC. |
| K161769 |
06/28/2016 |
Reprocessed Supreme Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
| K161827 |
07/05/2016 |
Reprocessed Response Diagnostic Electrophysiology Catheters |
INNOVATIVE HEALTH, LLC. |
| K162251 |
08/10/2016 |
Reprocessed Viking Diagnostic Electrophysiology Catheters |
Innovative Health, LLC. |
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