Chartis Catheter
510(k) K083883
Chartis Catheter is a Class II device made by Pulmonx Corporation, cleared under FDA 510(k) K083883 on 25 Jun 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083883 | Date25 Jun 2009 | StatusActive |
Official records
- FDA 510(k) database K083883
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CBI
- FDA applicant
- Pulmonx, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5740
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).
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