FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Chartis Precision Catheter
K Number: K253096
·
Decision Feb 13, 2026
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
33
Applicant Total
4
Review Days
143
Basic Information
- Device Name
- Chartis Precision Catheter
- K Number
- K253096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5740
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulmonx Corporation
- Date Received
- September 23, 2025
- Decision Date
- February 13, 2026
- Product Code
- CBI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
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Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
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