Data / Medical devices / United States / ENDOTRONIX (Naperville)
ENDOTRONIX (Naperville): FDA-registered device maker in Naperville, IL, United States, 1 510(k) clearance and 1 PMA approval
ENDOTRONIX (Naperville) is registered with the FDA (registration 3024985933) in Naperville, IL, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated June 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024985933
- Address
- 1415 WEST DIEHL ROAD Suite 500, Naperville, IL, United States, 60563
- Owner or operator
- Endotronix (10055645)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- November 21, 2018
- Registered through
- 2026
- Brand names listed
- Cordella Heart Failure System CHFS, Cordella Pulmonary Artery Sensor System, UA-651BLE, UC-352BLE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Hemodynamic, Implantable | MOM | 3 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2005 | K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 20, 2024 | P230040 | Cordella Pulmonary Artery Sensor System (CorPASS) | MOM | 34 | October 20, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Scale, Stand-On, Patient
- All makers of Cardiovascular Procedure Kit
- All makers of System, Hemodynamic, Implantable
Updated October 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.