Company ยท US
Innovative Health, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 24 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 7 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 6 |
| PNE | Reprocessed Catheter Introducer | 5 |
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | 3 |
| NMK | Trocar, Reprocessed | 2 |
| QLZ | Septostomy Catheter, Reprocessed | 2 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 1 |
| NLI | Catheter, Angiography, Reprocessed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2026 | K262917 | Reprocessed BRK Transseptal Needle Innovative Health, LLC | NMK |
| Jan 7, 2026 | K250305 | Reprocessed Agilis NxT Steerable Introducer Innovative Health | PNE |
| Jul 1, 2024 | K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters Innovative Health, LLC | NLI |
| Jun 7, 2024 | K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter Innovative Health | NLH |
| Apr 4, 2024 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath Innovative Health, LLC | PNE |
| Aug 7, 2023 | K230376 | Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC | PNE |
| Apr 4, 2023 | K213584 | Reprocessed NRG Transseptal Needle Innovative Health, LLC | QLZ |
| Aug 6, 2022 | K221854 | Reprocesses Umbilical Cable Innovative Health, LLC | NLH |
| May 25, 2022 | K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Innovative Health, LLC | OWQ |
| Mar 10, 2022 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath Innovative Health, LLC | PNE |
| Dec 20, 2021 | K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC | NLG |
| Nov 18, 2021 | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter Innovative Health, LLC | NLG |
| Sep 15, 2021 | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC | NLH |
| May 4, 2021 | K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Cathet Innovative Health, LLC | NLH |
| Mar 5, 2021 | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Nov 20, 2020 | K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Sep 3, 2020 | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC | MTD |
| Jul 30, 2020 | K200060 | Reprocessed NRG Transseptal Needle Innovative Health, LLC | QLZ |
| Jul 22, 2020 | K192998 | Reprocessed BRK Transseptal Needle Innovative Health, LLC | NMK |
| Jan 24, 2020 | K193263 | Reprocessed Achieve Catheter Connecting Cable Innovative Health, LLC | NLH |
| Dec 11, 2019 | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter Innovative Health, LLC | DRF |
| Oct 30, 2019 | K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter Innovative Health, LLC | NLH |
| Aug 23, 2019 | K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter Innovative Health, LLC | NLH |
| Jul 1, 2019 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Jun 25, 2019 | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter Innovative Health, LLC | NLG |
| Apr 23, 2019 | K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter Innovative Health, LLC | DRF |
| Feb 22, 2019 | K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter Innovative Health, LLC | NLH |
| Jan 18, 2019 | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter Innovative Health, LLC | OWQ |
| Nov 15, 2018 | K181897 | Reprocessed Marinr Diagnostic EP Catheter Innovative Health, LLC | NLH |
| Oct 27, 2018 | K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter Innovative Health, LLC | NLH |
| Oct 18, 2018 | K181618 | Reprocessed Torqr Diagnostic EP Catheter Innovative Health, LLC | NLH |
| Jun 19, 2018 | K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter Innovative Health, LLC | NLH |
| Mar 6, 2018 | K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Nov 3, 2017 | K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC | NLH |
| Oct 23, 2017 | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Oct 5, 2017 | K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter Innovative Health, LLC | NLH |
| Jul 12, 2017 | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Jun 22, 2017 | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Cathet Innovative Health, LLC | NLH |
| Jun 16, 2017 | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Jun 2, 2017 | K170311 | Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC | PNE |
| Dec 21, 2016 | K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters Innovative Health, LLC | NLH |
| Dec 8, 2016 | K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters Innovative Health, LLC | NLH |
| Dec 6, 2016 | K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters Innovative Health, LLC | DRF |
| Nov 2, 2016 | K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Cat Innovative Health, LLC | NLH |
| Oct 26, 2016 | K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter Innovative Health, LLC | NLH |
| Sep 30, 2016 | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC | NLH |
| Jun 10, 2016 | K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC | NLH |
| May 10, 2016 | K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter Innovative Health, LLC | NLH |
| May 10, 2016 | K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter Innovative Health, LLC | NLH |
| Mar 14, 2016 | K153153 | Reprocessed Electrophysiology Catheter Innovative Health, LLC | NLH |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||