Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003932293

FEI Number

3003932293

Entity Name

Trelleborg Sealing Solutions US, Inc

City/State/Country

Delano, MN, US

Establishment Address

740 7TH ST S, Delano, MN 55328, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Trelleborg Sealing Solutions US, Inc (Owner Number: 10059425)

Owner / Operator Contact Address

740 7th Street South, Delano, MN 55328, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cannula, Nasal, Oxygen Cannula, Nasal, Oxygen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-01-14
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2019-01-14
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2022-05-31
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2022-05-31
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2022-05-31
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-02-23
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2022-05-31
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2022-05-31

Official Correspondent

LuAna Remer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trelleborg Sealing Solutions US, 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
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2011	Boston Scientific CRM Corp	3	Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 CONTAK RENEWAL 4/4RF Models H190, H195, H197, H199, M170, M175, M177, M179, H230, H235, H239* *Not available in the US
Z-0025-2014	Boston Scientific CRM Corp	3	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Z-0026-2014	Boston Scientific CRM Corp	3	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Z-0035-2018	St Jude Medical Inc.	3	PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003932293. Last updated year: 2026. Please use registration number 3003932293 when referencing this establishment in official correspondence.