Pulmonx Corporation
Medical device manufacturer in Redwood City, CA.
9510(k) clearances
1PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253096 | Chartis Precision CatheterCBI · Traditional | 02/13/2026SE |
| K222340 | Chartis Precision CatheterCBI · Traditional | 12/01/2022SE |
| K212494 | Lung Image AnalysisJAK · Traditional | 09/02/2021SE |
| K180011 | Pulmonx Chartis Tablet ConsoleBZG · Traditional | 07/13/2018SE |
| K111764 | Chartis ConsoleBZG · Special | 11/10/2011SE |
| K111522 | Chartis Catheter Model CHR-CA-12.0CBI · Special | 09/29/2011SE |
| K083883 | Chartis CatheterCBI · Traditional | 06/25/2009SE |
| K083199 | Chartis ConsoleBZG · Traditional | 06/25/2009SE |
| K973191 | The Visualized Endotracheal Tube System or Vett SystemBTR · Traditional | 02/13/1998SE |
PMA approvals
- P180002 Zephyr Endobronchial Valve System · 06/29/2018 · 29 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0235-2024 Class II | Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LPEndobronchial implant devices may have been labeled with a shortened expiration date but they can be used… | 08/31/2023Open, Classified |