FDA.reportPublic FDA data

ENDOTRONIX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30249859333024985933ENDOTRONIX (Naperville)1N2026-01-011415 WEST DIEHL ROAD Suite 500 Naperville IL US 60563
30139005413013900541ENDOTRONIX1N2020-04-25815 Ogden Ave Lisle IL US 60532

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850008997006Cordella Sensor Delivery Kit - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.Cordella PA SensorThe Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.Delivery SystemThe Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.+1 888 512 5595support@endotronix.com
00850008997013myCordella Handheld Patient Reader - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.+1 888 512 5595support@endotronix.com
00850008997020Cordella Calibration Equipment - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System.The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include:• Interrogates the Cordella Sensor to verify proper working condition.• Facilitates linking of component serial numbers to patient IDs.• Calibrates the Cordella Sensor to a reference pressure at the time of implantation.• Trains patient on optimal Reader placement post-procedure.• Recalibrates the Cordella Sensor to a reference pressure post-implant.• CalEQ is operated by Endotronix personnel only.+1 888 512 5595support@endotronix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3106641769930661P230040Cordella Pulmonary Artery Sensor System (CorPASS)MOM2024-06-20
2106651325450110
2106651383843400
2106651865949467
3106641865949467

GUDID#

myCordella Patient Kit - myCordella Patient Kit consists of the myCordella Tablet and PeripheralsmyCordella TabletAn intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements.• Collects & securely transmits daily health information to doctors• Provides secure communication between patient and doctor• Provides access to patient education materials• Facilitates review of past measurements• Facilitates review of patient goalsmyCordella PeripheralsMedical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.

Endotronix, Inc.

2024-08-13

myCordella Handheld Patient Reader Alloy - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.

Endotronix, Inc.

2025-10-13

Cordella Sensor Delivery Kit - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.Cordella PA SensorThe Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.Delivery SystemThe Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.

Endotronix, Inc.

2024-08-14

Cordella Data Analysis Platform - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader dataand processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.

Endotronix, Inc.

2024-08-13

Cordella Calibration Equipment - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System.The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include:• Interrogates the Cordella Sensor to verify proper working condition.• Facilitates linking of component serial numbers to patient IDs.• Calibrates the Cordella Sensor to a reference pressure at the time of implantation.• Trains patient on optimal Reader placement post-procedure.• Recalibrates the Cordella Sensor to a reference pressure post-implant.• CalEQ is operated by Endotronix personnel only.

Endotronix, Inc.

2024-08-13

myCordella Handheld Patient Reader - The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.

Endotronix, Inc.

2024-08-13