Chartis Precision Catheter
FDA 510(k) clearance K222340 · decided 2022-12-01
Clearance details
- K-number
- K222340
- Device name
- Chartis Precision Catheter
- Applicant
- Pulmonx Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-08-03
- Decision date
- 2022-12-01
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pulmonx Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zephyr Endobronchial Valve System (P180002/S029) | Pulmonx Corporation | 2024-12-04 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S028) | Pulmonx Corporation | 2024-08-23 |
| Zephyr Endobronchial Valve System (P180002/S027) | Pulmonx Corporation | 2024-05-13 |
| Zephyr Endobronchial Valve System (P180002/S025) | Pulmonx Corporation | 2024-03-22 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S026) | Pulmonx Corporation | 2024-03-01 |
| modified 4.0-LP funnel component (P180002/S024) | Pulmonx Corporation | 2023-09-05 |
| Zephyr Valve Reigstry (ZEVR) (P180002/S022) | Pulmonx Corporation | 2023-03-25 |
| Zephyr Valve Registry (ZEVR) (P180002/S020) | Pulmonx Corporation | 2022-03-09 |