ENDOTRONIX (Naperville)

FDA Device Registration & Listing · Naperville, IL, US · Registration 3024985933

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024985933
FEI Number
3024985933
Entity Name
ENDOTRONIX (Naperville)
City/State/Country
Naperville, IL, US
Establishment Address
1415 WEST DIEHL ROAD Suite 500, Naperville, IL 60563, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Endotronix (Owner Number: 10055645)
Owner / Operator Contact Address
1415 West Diehl Road, Suite 500, Naperville, IL 60563, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cordella Pulmonary Artery Sensor System Cordella Heart Failure System CHFS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOM System, Hemodynamic, Implantable Unknown Class 3 N/A 2024-06-24
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2018-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endotronix
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3005308195 SALINE LECTRONICS Saline, MI, US
3011706799 Abbott Medical Atlanta, GA, US
2916596 THORATEC CORP. PLEASANTON, CA, US
3038966819 UIM PRESSURE IMPLANT INC Ypsilanti, MI, US
2184149 St. Jude Medical, Atrial Fibrillation Division, Inc. Saint Paul, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024985933. Last updated year: 2026. Please use registration number 3024985933 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.