Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016842760

FEI Number

3016842760

Entity Name

MIDWEST INTERVENTIONAL SYSTEMS

City/State/Country

Maple Grove, MN, US

Establishment Address

6450 Wedgwood Rd N, STE 110, Maple Grove, MN 55311, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Midwest Interventional Systems (Owner Number: 10073120)

Owner / Operator Contact Address

6450 Wedgwood Rd N, STE 110, Maple Grove, MN 55311, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Osteo-site Vertebral Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2025-12-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-12-12
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2023-07-21
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-07-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Midwest Interventional Systems

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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K171761	Acclarent, Inc.	ACCLARENT AERA Eustachian Tube Balloon Dilation System	2018-01-16
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3015309643	Merit Medical UK Limited	Earley Reading, GB
3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016842760. Last updated year: 2026. Please use registration number 3016842760 when referencing this establishment in official correspondence.