Data / Medical devices / United States / Innovative Health, LLC.
Innovative Health, LLC.: FDA-registered device maker in Scottsdale, AZ, United States, 36 510(k) clearances
Innovative Health, LLC. is registered with the FDA (registration 3011610434) in Scottsdale, AZ, United States. It lists 11 device types. The FDA files 36 510(k) clearances under its listings, the newest dated January 7, 2026. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011610434
- Address
- 1435 N. Hayden Road Suite 100, Scottsdale, AZ, United States, 85257
- Owner or operator
- Innovative Health, LLC. (10048854)
- Roles
- Reprocessor
- First device listed
- March 10, 2015
- Registered through
- 2027
- Brand names listed
- Reprocessed AcuNav Diagnostic Ultrasound Catheter, Reprocessed Bi-Directional Guiding Sheath, Reprocessed Cable, Reprocessed Catheter Connecting Cable, Reprocessed Diagnostic Electrophysiology Catheter, Reprocessed Diagnostic Ultrasound Catheter, Reprocessed Digital IVUS Catheter, Reprocessed Electrophysiology Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Reprocessor | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Reprocessor | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Reprocessor | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | 2 | Reprocessor | accessdata.fda.gov |
| Catheter, Recording, Electrode, Reprocessed | NLH | 2 | Reprocessor | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Reprocessor | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Reprocessor | accessdata.fda.gov |
| Reprocessed Catheter Introducer | PNE | 2 | Reprocessor | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 2 | Reprocessor | accessdata.fda.gov |
| Septostomy Catheter, Reprocessed | QLZ | 2 | Reprocessor | accessdata.fda.gov |
| Trocar, Reprocessed | NMK | 2 | Reprocessor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 7, 2026 | K250305 | Reprocessed Agilis NxT Steerable Introducer | PNE | Substantially Equivalent | Innovative Health | accessdata.fda.gov |
| June 7, 2024 | K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health | accessdata.fda.gov |
| April 4, 2024 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | PNE | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| April 4, 2023 | K213584 | Reprocessed NRG Transseptal Needle | QLZ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| August 6, 2022 | K221854 | Reprocesses Umbilical Cable | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| May 25, 2022 | K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| March 10, 2022 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | PNE | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| December 20, 2021 | K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | NLG | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| November 18, 2021 | K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | NLG | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| September 15, 2021 | K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| May 4, 2021 | K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| March 5, 2021 | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | DRF | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| November 20, 2020 | K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | OWQ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| July 22, 2020 | K192998 | Reprocessed BRK Transseptal Needle | NMK | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| January 24, 2020 | K193263 | Reprocessed Achieve Catheter Connecting Cable | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| December 11, 2019 | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | DRF | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| August 23, 2019 | K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| June 25, 2019 | K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | NLG | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| April 23, 2019 | K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | DRF | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| February 22, 2019 | K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| November 15, 2018 | K181897 | Reprocessed Marinr Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| October 27, 2018 | K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| October 18, 2018 | K181618 | Reprocessed Torqr Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| June 19, 2018 | K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| November 3, 2017 | K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| October 5, 2017 | K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| July 12, 2017 | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | OWQ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| June 22, 2017 | K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| June 16, 2017 | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | OWQ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| December 21, 2016 | K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| November 2, 2016 | K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| October 26, 2016 | K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| September 30, 2016 | K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| June 10, 2016 | K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| May 10, 2016 | K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| March 14, 2016 | K153153 | Reprocessed Electrophysiology Catheter | NLH | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Catheter, Recording, Electrode, Reprocessed
- All makers of Cable, Electrode
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Reprocessed Intravascular Ultrasound Catheter
- All makers of Reprocessed Catheter Introducer
Updated January 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.