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510(k) K083883

CHARTIS CATHETER by Pulmonx, Inc. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2009
Date Received
December 29, 2008
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, Inc.

  • K111764 — CHARTIS CONSOLE (November 10, 2011)
  • K111522 — CHARTIS CATHETER MODEL CHR-CA-12.0 (September 29, 2011)
  • K083199 — CHARTIS CONSOLE (June 25, 2009)
  • K973191 — THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM (February 13, 1998)

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  • 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)
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