Chartis Precision Catheter

The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic…

Registry build 21.09.26

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

4manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Henan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code CBI
Manufacturer City Province Registered as Device types
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Henan Tuoren Medical Device Co., Ltd. Changyuan Henan Manufacturer 5
Hangzhou Tappa Medical Technology Co., Ltd. Hangzhou Zhejiang Manufacturer 3

Record

Regulatory record for Chartis Precision Catheter
Listed by Pulmonx, Corp., United States
FDA product code CBI
Device type Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class Class 2
Regulation 21 CFR 868.5740
Establishment Complaint-file establishment, Manufacturer, Exporter
Record published 2024-03-15

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store at room temperature in a clean and dry environment.
Sizes Catheter working length 72 cm; balloon diameter 13 mm; length 145 cm

Catalogue Numbers

Catalogue numbers for Chartis Precision Catheter
Catalogue number Size Status
G4 Catheter Working Length 72 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Insighters Shenzhen Insighters Medical Technology Co., Ltd. 39
Rusch Teleflex Medical LLC 26
Univent Tube (TCB Type) Fuji Systems Corp. 22
Hudson RCI Teleflex Medical LLC 21
Sheridan Teleflex Medical LLC 19
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Henan Tuoren Medical Device Co., Ltd. 18
Parker Flex-Tip Salter Labs 18
Parker Salter Labs 17
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Hangzhou Tappa Medical Technology Co., Ltd. 12
Forsure Forsure Medical Products LLC. 12
Endobronchial Tube Well Lead Medical Co., Ltd. 12
Portex ICU Medical, Inc 11

Showing 12 of 29. All products under Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253096 2026-02-13
K222340 2022-12-01
K111522 2011-09-29
K083883 2009-06-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer