Home / 510(k) Clearances / K111522

510(k) K111522

CHARTIS CATHETER MODEL CHR-CA-12.0 by Pulmonx, Inc. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
June 2, 2011
Clearance Type
Special
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, Inc.

  • K111764 — CHARTIS CONSOLE (November 10, 2011)
  • K083199 — CHARTIS CONSOLE (June 25, 2009)
  • K083883 — CHARTIS CATHETER (June 25, 2009)
  • K973191 — THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM (February 13, 1998)

Other clearances for product code CBI

  • K253096 — Chartis Precision Catheter (February 13, 2026)
  • 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)