Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024996452

FEI Number

3024996452

Entity Name

CIRTEC MEDICAL

City/State/Country

Brooklyn Park, MN, US

Establishment Address

9315 Winnetka Ave N, Brooklyn Park, MN 55445, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cirtec Medical Corporation (Owner Number: 10025422)

Owner / Operator Contact Address

9200 Xylon Ave N, Brooklyn Park, MN 55445, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

canturio Electrode, Depth Electrode, Cortical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	Orthopedic	Class 2	888.3600	2021-09-07
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2022-11-02
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2022-11-02
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2022-11-02
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2022-11-02
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2025-08-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cirtec Medical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016618265	Cirtec Medical	Coyol Alajuela, CR
3013368220	CIRTEC MEDICAL	Brooklyn Park, MN, US
3004737415	Cirtec Medical	Santa Clara, CA, US
3009183442	Cirtec Medical	Enfield, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2025	Inspire Medical Systems Inc.	3	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Z-0041-2025	Inspire Medical Systems Inc.	3	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Similar Registrations

Registration Number	Establishment Name	Location
3013368220	CIRTEC MEDICAL	Brooklyn Park, MN, US
3015802419	CANARY MEDICAL USA LLC	Carlsbad, CA, US
1828288	ORCHID UNIQUE	Bridgeport, MI, US
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024996452. Last updated year: 2026. Please use registration number 3024996452 when referencing this establishment in official correspondence.