INNOVATIVE HEALTH, LLC.

FDA Device Registration & Listing · Scottsdale, AZ, US · Registration 3011610434

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011610434
FEI Number
3011610434
Entity Name
INNOVATIVE HEALTH, LLC.
City/State/Country
Scottsdale, AZ, US
Establishment Address
1435 N. Hayden Road, Suite 100, Scottsdale, AZ 85257, US
Establishment Type(s)
Reprocess Single-Use Device
Owner / Operator
Innovative Health, LLC. (Owner Number: 10048854)
Owner / Operator Contact Address
1435 N. Hayden Road, Suite 100, Scottsdale, AZ 85257, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232037
PMA Number
N/A

All Registered Proprietary Names

Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Transseptal Needle Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Mapping Diagnostic Electrophysiology Catheter Reprocessed Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed NRG Transseptal Needle Reprocessed Digital IVUS Catheter Reprocessed Cable Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Bi-Directional Guiding Sheath Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Mapping Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Diagnostic Ultrasound Catheter Reprocessed Steerable Introducer Reprocessed Diagnostic Electrophysiology Catheter Reprocessed Steerable Introducer Reprocessed Mapping Catheter Reprocessed Transseptal Needle Reprocessed Steerable/Guiding Sheath

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2018-11-12
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-11-12
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2017-11-09
NMK Trocar, Reprocessed Cardiovascular Class 2 870.1390 2020-07-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-08
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-12-08
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-10-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2021-10-18
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-10-18
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2019-12-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2019-12-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-06-03
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2017-02-11
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2017-02-11
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2017-10-26
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2017-10-26
QLZ Septostomy Catheter, Reprocessed Cardiovascular Class 2 870.5175 2020-08-03
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2022-09-16
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2022-09-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2022-12-01
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2019-07-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2019-07-16
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2022-03-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-15
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2018-06-25
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2018-06-25
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2019-06-28
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed Cardiovascular Class 2 870.1220 2019-06-28
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2019-07-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2019-07-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-10-16
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-10-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2017-08-04
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2017-08-04
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2020-11-24
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-11-24
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2017-06-30
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-06-04
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2021-06-04
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2026-01-08
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed Cardiovascular Class 2 870.1220 2022-01-04
QLZ Septostomy Catheter, Reprocessed Cardiovascular Class 2 870.5175 2023-04-17
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2024-05-23

Official Correspondent

Angelica McParlane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Innovative Health, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17
K150357 Sterilmed, Inc. Reprocessed Electrophysiology Diagnostic Catheters 2015-08-27
K043393 Alliance Medical Corp. REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS 2005-03-23
K251211 ABBOTT MEDICAL ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ 2025-05-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2016 Biosense Webster, Inc. 2
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011610434. Last updated year: 2026. Please use registration number 3011610434 when referencing this establishment in official correspondence.
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