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510(k) K253096

Chartis Precision Catheter by Pulmonx Corporation — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
September 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

Other clearances by Pulmonx Corporation

  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K212494 — Lung Image Analysis (September 2, 2021)
  • K180011 — Pulmonx Chartis Tablet Console (July 13, 2018)

Other clearances for product code CBI

  • K232529 — Disposable Double Lumen Endobronchial Tube (May 13, 2024)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)
  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K201026 — sOLVe Tube (August 10, 2021)
  • K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (May 3, 2021)
  • K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (December 28, 2020)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)
  • K160542 — 5.0 Fr Arndt Endobronchial Blocker Set (August 2, 2016)
  • K152251 — Endobronchial Tube (June 10, 2016)