Chartis Catheter
Basic Information
- Brand Name
- Chartis Catheter
- Primary DI
- M776CHRCA120
- Version / Model
- G3
- Catalog Number
- CHR-CA-12.0
- Company Name
- PULMONX CORPORATION
- Labeler DUNS
- 958582595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d1ff2a18-864d-4026-9b94-8fdff30c0fec
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Anesthesiology | 868.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17827 | Bronchial balloon catheter | A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M776CHRCA120 | HIBCC |
Customer Contacts
- Phone
- 650-216-0165
- [email protected]
- Phone
- 650-364-0400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111522 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.7 | Millimeter | |
| Total Volume | 3 | Milliliter | |
| Length | 72 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius