FDA Registration
Active
🇺🇸 United States
MINNETRONIX, INC.
Reg #: 2133810
·
FEI: 3000203066
·
Expires 2026
Products
31
Proprietary Names
33
Establishment Types
2
Classifications
31
Registration Details
- Registration Name
- MINNETRONIX, INC.
- Registration Number
- 2133810
- FEI Number
- 3000203066
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1635 ENERGY PARK DR.
- City
- Saint Paul
- State
- MN
- ZIP
- 55108
- Country
- US
Owner / Operator
- Firm Name
- Minnetronix Medical, Inc.
- Operator Number
- 9033484
- Address
- 1635 ENERGY PARK DR., --
- City
- Saint Paul
- State
- MN
- Postal Code
- 55108
- Country
- US
- Correspondent
- Mary Stietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-04-08 |
| Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | OCM | Class 3 | Unknown | No | 2024-09-12 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2013-12-09 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2017-06-30 |
| Apparatus, Nitric Oxide Delivery | MRN | Class 2 | Anesthesiology | No | 2021-05-11 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2013-12-09 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-06-26 |
| Catheter, Coronary, Atherectomy | MCX | Class 3 | Unknown | No | 2008-01-11 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2020-03-03 |
| Pressure Ulcer Management Tool | QEF | Class 1 | Gastroenterology, Urology | No | 2023-06-27 |
| Transdermal Test For Assessment Of Glomerular Filtration Rate | SDK | Class 3 | Unknown | No | 2026-02-13 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2017-11-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-07-01 |
| Sensor, Glucose, Implanted, Non-Adjunctive Use | QHJ | Class 3 | Unknown | No | 2023-07-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-04-27 |
| Continuous Glucose Monitor, Implanted, Adjunctive Use | QCD | Class 3 | Unknown | No | 2023-07-12 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-04-27 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-04-27 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2024-09-12 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2019-12-18 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2025-07-02 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2024-09-19 |
| Device, Warming. Blood And Plasma | KZL | Class 2 | Hematology | No | 2021-01-07 |
| Light Based Device For Dry Age-Related Macular Degeneration | SDE | Class 2 | Ophthalmic | No | 2024-11-14 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2026-03-28 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2021-01-25 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-03-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-06-28 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2018-10-08 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2025-05-14 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2025-05-14 |
Proprietary Names
Venclose Maven System digiRF Generator
Multifunctional Ablation Generator; Synergy Ablation System
Cortrak Enteral Access Device
Heartlight Endoscopic Ablation Console
GENOSYL DS
EPi-Sense® Guided Coagulation System; Multifunctional Ablation Generator
Heartware LVAD Controller, Monitor and DC Adapter
Pristine Arthroscopic Visualization System
Angiojet Ultra Thrombectomy Console
VeinViewer Flex; VeinViewer Vision, VeinViewer Vision2
Provizio SEM Scanner
MediBeacon Transdermal GFR System
Intact Gen2 System
Lantern Navigation System
CORTRAK* 2 Equilateral Enteral Access System
Eversense Continuous Glucose Monitoring System; Eversense E3 Continuous Glucose Monitoring System
Viamo c100 TUS-VC-100 Diagnostic Ultrasound System
Multifunctional Ablation Generator
Venclose System digiRF Generator
Skylife Phototherapy
identifeye Camera System
Vitalflow Console
Zip Thaw 202
Valeda Light Delivery System
Embrace One; HomeStream Remote Management; Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead;
MindsEye Expandable Port
Ablamap System
CORTRAK 2 Enteral Access Device
AthroFree
Level 1 Convective Warmer
MiniBox+
InterVapor Generator
Ablation Generator System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only