FDA Registration
Active
🇺🇸 United States
INNOVATIVE HEALTH, LLC.
Reg #: 3011610434
·
FEI: 3011610434
·
Expires 2026
Products
11
Proprietary Names
15
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- INNOVATIVE HEALTH, LLC.
- Registration Number
- 3011610434
- FEI Number
- 3011610434
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1435 N. Hayden Road, Suite 100
- City
- Scottsdale
- State
- AZ
- ZIP
- 85257
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181458
Owner / Operator
- Firm Name
- Innovative Health, LLC.
- Operator Number
- 10048854
- Address
- 1435 N. Hayden Road, Suite 100
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85257
- Country
- US
- Correspondent
- Angelica McParlane
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2018-11-12 |
| Catheter, Recording, Electrode, Reprocessed | NLH | Class 2 | Cardiovascular | No | 2018-11-12 |
| Trocar, Reprocessed | NMK | Class 2 | Cardiovascular | No | 2020-07-27 |
| Septostomy Catheter, Reprocessed | QLZ | Class 2 | Cardiovascular | No | 2020-08-03 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2022-09-16 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2022-09-16 |
| Reprocessed Catheter Introducer | PNE | Class 2 | Cardiovascular | No | 2022-03-15 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-03-15 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2019-06-28 |
| Catheter, Intracardiac Mapping, High-Density, Reprocessed | NLG | Class 2 | Cardiovascular | No | 2019-06-28 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2015-03-10 |
Proprietary Names
Reprocessed Diagnostic Electrophysiology Catheter
Reprocessed Transseptal Needle
Reprocessed Mapping Diagnostic Electrophysiology Catheter
Reprocessed Electrophysiology Catheter
Reprocessed NRG Transseptal Needle
Reprocessed Digital IVUS Catheter
Reprocessed Cable
Reprocessed Bi-Directional Guiding Sheath
Reprocessed Mapping Catheter
Reprocessed Diagnostic Ultrasound Catheter
Reprocessed Steerable Introducer
Reprocessed Steerable/Guiding Sheath
Reprocessed Catheter Connecting Cable
Reprocessed AcuNav Diagnostic Ultrasound Catheter
Reprocessed Mapping Catheter Sensor Enabled
Establishment Types
Reprocess Single-Use Device