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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.
100102-01
In Commercial Distribution
- 00850008997013 ()
- Implantable pulmonary artery pressure monitoring system
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 Sensor
The 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 System
The 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.
100303-05
In Commercial Distribution
- 00850008997006 ()
- Implantable pulmonary artery pressure monitoring system
No Description
CHANNEL MEDSYSTEMS, INC.
FGS-7000
In Commercial Distribution
- 00850008595035 ()
- Hand-held cryosurgical system
Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device
CHANNEL MEDSYSTEMS, INC.
FGS-7015
In Commercial Distribution
- 00850008595042 ()
- General cryosurgical system, cryogen gas, electronic
PROG-004 Kit (US)
Avertix Medical Inc.
0217-2100-004#P18
In Commercial Distribution
- 00850012625162 ()
0217-2100-004#P18
- Implantable cardiac device management application software
ActaStim-S Spine Fusion Stimulator - Shower Covers, Electrode
THERAGEN, LLC
4101-0002
In Commercial Distribution
- 00850372007257 ()
- Patient-worn bone growth electromagnetic stimulator
ActaStim-S Spine Fusion Stimulator System
THERAGEN, LLC
1101-0000
In Commercial Distribution
- 00850372007240 ()
1101-0000
- Patient-worn bone growth electromagnetic stimulator
Electroconvulsive Therapy Instrument
SOMATICS, LLC
System IV
In Commercial Distribution
- 00850298007003 ()
- Weight: 22 Pound
- Depth: 5.25 Inch
- Height: 13 Inch
- Width: 18 Inch
EDIV
- Electroporation therapy system generator
No Description
Trilliant Surgical, LLC
920-0061-04
In Commercial Distribution
- 00850062461949 ()
- Orthopaedic implant impactor, reusable
Reconstitution Buffer, 10% Albumin in Tris buffered solution, antimicrobial agent (800 mL)
EXACT SCIENCES CORPORATION
100542
In Commercial Distribution
- 00850057859034 ()
- Faecal occult blood IVD, reagent