Innovative Health, LLC
FDA 510(k) & PMA Approved Devices — 48 products
Total Devices48
Categories9
Latest Approval2024-07-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | NLI | 2024-07-01 | View |
| 510(k) | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | PNE | 2024-04-04 | View |
| 510(k) | K230376 | Reprocessed Agilis NxT Steerable Introducer | PNE | 2023-08-07 | View |
| 510(k) | K213584 | Reprocessed NRG Transseptal Needle | QLZ | 2023-04-04 | View |
| 510(k) | K221854 | Reprocesses Umbilical Cable | NLH | 2022-08-06 | View |
| 510(k) | K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | 2022-05-25 | View |
| 510(k) | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | PNE | 2022-03-10 | View |
| 510(k) | K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | NLG | 2021-12-20 | View |
| 510(k) | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | NLG | 2021-11-18 | View |
| 510(k) | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | NLH | 2021-09-15 | View |
| 510(k) | K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | 2021-05-04 | View |
| 510(k) | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | DRF | 2021-03-05 | View |
| 510(k) | K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | OWQ | 2020-11-20 | View |
| 510(k) | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | 2020-09-03 | View |
| 510(k) | K200060 | Reprocessed NRG Transseptal Needle | QLZ | 2020-07-30 | View |
| 510(k) | K192998 | Reprocessed BRK Transseptal Needle | NMK | 2020-07-22 | View |
| 510(k) | K193263 | Reprocessed Achieve Catheter Connecting Cable | NLH | 2020-01-24 | View |
| 510(k) | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | DRF | 2019-12-11 | View |
| 510(k) | K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | NLH | 2019-10-30 | View |
| 510(k) | K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | NLH | 2019-08-23 | View |
| 510(k) | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | DRF | 2019-07-01 | View |
| 510(k) | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | NLG | 2019-06-25 | View |
| 510(k) | K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | DRF | 2019-04-23 | View |
| 510(k) | K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | NLH | 2019-02-22 | View |
| 510(k) | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | OWQ | 2019-01-18 | View |
| 510(k) | K181897 | Reprocessed Marinr Diagnostic EP Catheter | NLH | 2018-11-15 | View |
| 510(k) | K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | NLH | 2018-10-27 | View |
| 510(k) | K181618 | Reprocessed Torqr Diagnostic EP Catheter | NLH | 2018-10-18 | View |
| 510(k) | K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | NLH | 2018-06-19 | View |
| 510(k) | K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | OWQ | 2018-03-06 | View |
| 510(k) | K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | NLH | 2017-11-03 | View |
| 510(k) | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | DRF | 2017-10-23 | View |
| 510(k) | K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | NLH | 2017-10-05 | View |
| 510(k) | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | OWQ | 2017-07-12 | View |
| 510(k) | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | 2017-06-22 | View |
| 510(k) | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | OWQ | 2017-06-16 | View |
| 510(k) | K170311 | Reprocessed Agilis NxT Steerable Introducer | PNE | 2017-06-02 | View |
| 510(k) | K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters | NLH | 2016-12-21 | View |
| 510(k) | K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters | NLH | 2016-12-08 | View |
| 510(k) | K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters | DRF | 2016-12-06 | View |
| 510(k) | K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter | NLH | 2016-11-02 | View |
| 510(k) | K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | NLH | 2016-10-26 | View |
| 510(k) | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | NLH | 2016-09-30 | View |
| 510(k) | K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | NLH | 2016-06-10 | View |
| 510(k) | K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | NLH | 2016-05-10 | View |
| 510(k) | K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter | NLH | 2016-05-10 | View |
| 510(k) | K153153 | Reprocessed Electrophysiology Catheter | NLH | 2016-03-14 | View |
| 510(k) | K153090 | Reprocessed Diagnostic Ultrasound Catheter | OWQ | 2016-03-10 | View |
No matching devices.