Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133810

FEI Number

3000203066

Entity Name

MINNETRONIX, INC.

City/State/Country

Saint Paul, MN, US

Establishment Address

1635 ENERGY PARK DR., Saint Paul, MN 55108, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Minnetronix Medical, Inc. (Owner Number: 9033484)

Owner / Operator Contact Address

1635 ENERGY PARK DR., --, Saint Paul, MN 55108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-04-08
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2024-09-12
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-12-09
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2017-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2021-05-11
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2024-09-12
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2013-12-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-06-26
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2008-01-11
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2020-03-03
QEF	Pressure Ulcer Management Tool	Gastroenterology, Urology	Class 1	876.2100	2023-06-27
SDK	Transdermal Test For Assessment Of Glomerular Filtration Rate	Unknown	Class 3	N/A	2026-02-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-11-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-01
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-05-20
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use	Unknown	Class 3	N/A	2023-07-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-04-27
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use	Unknown	Class 3	N/A	2023-07-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-04-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-04-27
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2024-09-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-04-08
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2019-12-18
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2025-07-02
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	Class 2	870.4100	2024-09-19
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2021-01-07

Official Correspondent

Mary Stietz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Minnetronix Medical, Inc.

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0004-2007	Thoratec Corp	3	Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Z-0005-2017	Heartware, Inc.	3	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133810. Last updated year: 2026. Please use registration number 2133810 when referencing this establishment in official correspondence.