PULMONX, Corp.

FDA Registration(s)#

GUDID Contact Samples#

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

• pulmonx.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Zephyr Valve Registry (ZEVR)

  2022-03-09

  Pulmonx Corporation700 Chesapeake Driveredwood City, CA 94063 PMA NumberP180002 Supplement NumberS020 Date Received02/07/2022 Decision Date03/09/2022 Product Code NJK  Advisory Committee Anesthesiology Supplement Typenormal 180 Day Track No User Fee Supplem...

• Zephyr Endobronchial Valve (Zephyr Valve)

  2021-08-13

  Pulmonx Corporation

• Zephyr Endobronchial Valve System

  2020-11-19

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2020-10-30

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2020-10-06

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2019-12-06

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2019-11-21

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2019-11-21

  Pulmonx Corporation

• Zephyr 5.5 EBV Circle Flange Valve

  2019-11-13

  Pulmonx Corporation

• Zephyr Valve Registry (ZEVR)

  2019-10-02

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2019-07-19

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2019-07-17

  Pulmonx Corporation

• Zephyr Endobronchial Valve System

  2019-01-28

  Pulmonx Corporation

• Zephyr Endobronchial Valve (EBV) System

  2018-10-25

  Pulmonx Corporation

• Pulmonx Zephyr Endobronchial Valve (EBV)

  2018-09-25

  Pulmonx Corporation

• Zephyr Endobronchial Valve System

  2018-06-29

  Pulmonx Corporation

PMN#

• Chartis Precision Catheter

  2022-12-01

  Pulmonx Corporation

• Lung Image Analysis

  2021-09-02

  Pulmonx Corporation

• Pulmonx Chartis Tablet Console

  2018-07-13

  Pulmonx Corporation

• CHARTIS CONSOLE

  2011-11-10

  PULMONX, INC.

• CHARTIS CATHETER MODEL CHR-CA-12.0

  2011-09-29

  PULMONX, INC.

• CHARTIS CONSOLE

  2009-06-25

  PULMONX, INC.

• CHARTIS CATHETER

  2009-06-25

  PULMONX, INC.

• THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM

  1998-02-13

  PULMONX

GUDID#

• Chartis Precision Catheter - The Chartis Precision Catheter is a single use, sterile, disposable device designed to be insertedinto the working channel of a standard video or fiber bronchoscope during a diagnosticbronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, thedistal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directlyinto the target airway. Inflation of the compliant balloon on the distal tip of the Chartis PrecisionCatheter causes the airway to become sealed and isolated. Air can then flow out of the isolatedlung compartment into the environment only through the central lumen of the Chartis PrecisionCatheter. Assessment is accomplished by measuring air flows and pressures exiting the ChartisPrecision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the ChartisConsole.

  PULMONX CORPORATION

  2024-03-15

• Lung Image Analysis - The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.

  PULMONX CORPORATION

  2022-09-05

• Pulmonx Chartis Tablet Console - The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. Theballoon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

  PULMONX CORPORATION

  2021-04-20

• Chartis Console - The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device.

  PULMONX CORPORATION

  2016-03-25

• Pulmonx Chartis Tablet Console - The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Endobronchial Valve - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2019-08-23

• Zephyr Delivery Catheter - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2019-08-23

• Chartis Catheter - The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter.

  PULMONX CORPORATION

  2018-10-03

• Zephyr Endobronchial Valve - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Endobronchial Valve - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Endobronchial Valve - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Delivery Catheter - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Delivery Catheter - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Zephyr Delivery Catheter - The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.

  PULMONX CORPORATION

  2018-07-20

• Chartis Catheter - The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter.

  PULMONX CORPORATION

  2016-03-25