Innovative Health, LLC.

Scottsdale, AZ, US

INNOVATIVE HEALTH, LLC. appears in FDA device records in Scottsdale, AZ. FDA records list 50 510(k) clearances between 2016-03-10 and 2026-01-07, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 50
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 50 510(k) clearances for Innovative Health, LLC. between 2016 and 2026. The busiest year on record is 2016, with 11. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Innovative Health, LLC., by decision year
Year	Clearances
2016	11
2017	7
2018	5
2019	8
2020	5
2021	5
2022	3
2023	2
2024	3
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250305	Reprocessed Agilis NxT Steerable Introducer	PNE	Substantially Equivalent	2026-01-07
K231015	Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters	NLI	Substantially Equivalent	2024-07-01
K233825	Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter	NLH	Substantially Equivalent	2024-06-07
K232037	Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath	PNE	Substantially Equivalent	2024-04-04
K230376	Reprocessed Agilis NxT Steerable Introducer	PNE	Substantially Equivalent	2023-08-07
K213584	Reprocessed NRG Transseptal Needle	QLZ	Substantially Equivalent	2023-04-04
K221854	Reprocesses Umbilical Cable	NLH	Substantially Equivalent	2022-08-06
K210655	Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	OWQ	Substantially Equivalent	2022-05-25
K212165	Reprocessed Carto Vizigo Bi-Directional Guiding Sheath	PNE	Substantially Equivalent	2022-03-10
K212776	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled	NLG	Substantially Equivalent	2021-12-20
K211662	Reprocessed IntellaMap Orion High Resolution Mapping Catheter	NLG	Substantially Equivalent	2021-11-18
K211276	Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters	NLH	Substantially Equivalent	2021-09-15
K203655	Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)	NLH	Substantially Equivalent	2021-05-04
K203261	Reprocessed Inquiry Steerable Diagnostic EP Catheter	DRF	Substantially Equivalent	2021-03-05
K202042	Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter	OWQ	Substantially Equivalent	2020-11-20
K200212	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled	MTD	Substantially Equivalent	2020-09-03
K200060	Reprocessed NRG Transseptal Needle	QLZ	Substantially Equivalent	2020-07-30
K192998	Reprocessed BRK Transseptal Needle	NMK	Substantially Equivalent	2020-07-22
K193263	Reprocessed Achieve Catheter Connecting Cable	NLH	Substantially Equivalent	2020-01-24
K191880	Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter	DRF	Substantially Equivalent	2019-12-11
K191170	Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter	NLH	Substantially Equivalent	2019-10-30
K190127	Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter	NLH	Substantially Equivalent	2019-08-23
K190980	Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter	DRF	Substantially Equivalent	2019-07-01
K190785	Reprocessed PentaRay Nav eco High-Density Mapping Catheter	NLG	Substantially Equivalent	2019-06-25
K182386	Reprocessed Supreme Diagnostic Electrophysiology Catheter	DRF	Substantially Equivalent	2019-04-23
K182488	Reprocessed Response Diagnostic Electrophysiology Catheter	NLH	Substantially Equivalent	2019-02-22
K181126	Reprocessed Visions PV .035 Digital IVUS Catheter	OWQ	Substantially Equivalent	2019-01-18
K181897	Reprocessed Marinr Diagnostic EP Catheter	NLH	Substantially Equivalent	2018-11-15
K181458	Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter	NLH	Substantially Equivalent	2018-10-27
K181618	Reprocessed Torqr Diagnostic EP Catheter	NLH	Substantially Equivalent	2018-10-18
K180710	Reprocessed DecaNav Diagnostic Electrophysiology Catheter	NLH	Substantially Equivalent	2018-06-19
K173262	Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter	OWQ	Substantially Equivalent	2018-03-06
K171788	Reprocessed Halo XP Diagnostic Electrophysiology Catheter	NLH	Substantially Equivalent	2017-11-03
K171277	Reprocessed Inquiry Steerable Diagnostic EP Catheter	DRF	Substantially Equivalent	2017-10-23
K171503	Reprocessed CristaCath Diagnostic Electrophysiology Catheter	NLH	Substantially Equivalent	2017-10-05
K163560	Reprocessed AcuNav Diagnostic Ultrasound Catheter	OWQ	Substantially Equivalent	2017-07-12
K170922	Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)	NLH	Substantially Equivalent	2017-06-22
K170474	Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter	OWQ	Substantially Equivalent	2017-06-16
K170311	Reprocessed Agilis NxT Steerable Introducer	PNE	Substantially Equivalent	2017-06-02
K162251	Reprocessed Viking Diagnostic Electrophysiology Catheters	NLH	Substantially Equivalent	2016-12-21
K161827	Reprocessed Response Diagnostic Electrophysiology Catheters	NLH	Substantially Equivalent	2016-12-08
K161769	Reprocessed Supreme Diagnostic Electrophysiology Catheters	DRF	Substantially Equivalent	2016-12-06
K160421	Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter	NLH	Substantially Equivalent	2016-11-02
K161393	Reprocessed Orbiter ST Steerable Diagnostic EP Catheter	NLH	Substantially Equivalent	2016-10-26
K161464	Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters	NLH	Substantially Equivalent	2016-09-30
K160496	Reprocessed Inquiry Steerable Diagnostic EP Catheter	NLH	Substantially Equivalent	2016-06-10
K160303	Reprocessed Polaris X Steerable Diagnostic EP Catheter	NLH	Substantially Equivalent	2016-05-10
K160242	Reprocessed Livewire Steerable Diagnostic EP Catheter	NLH	Substantially Equivalent	2016-05-10
K153153	Reprocessed Electrophysiology Catheter	NLH	Substantially Equivalent	2016-03-14
K153090	Reprocessed Diagnostic Ultrasound Catheter	OWQ	Substantially Equivalent	2016-03-10

Registered establishments

FDA registered establishments for Innovative Health, LLC., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011610434	3011610434	INNOVATIVE HEALTH, LLC.	1435 N. Hayden Road, Scottsdale, AZ 85257 US	2026	DRF DYB IKD MTD NLG NLH NMK OBJ OWQ PNE and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Innovative Health, LLC. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain