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510(k) K181886

VivaSight-DL System by Etview , Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2018
Date Received
July 13, 2018
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 Etview , Ltd.

  • K181880 — VivaSight-SL (TVT) system (November 29, 2018)
  • K152438 — ETView VivaSight-SL (TVT) system (February 25, 2016)
  • K123853 — VIVASIGHT-DL SYSTEM (April 15, 2013)
  • K121028 — ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) (June 21, 2012)
  • K120334 — VIVA EB (June 8, 2012)
  • K113576 — DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM (May 18, 2012)
  • K082420 — TRACHEOSCOPIC VENTILATION TUBE (TVT) (October 8, 2008)
  • K052233 — TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM (December 13, 2005)

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)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)
  • K160542 — 5.0 Fr Arndt Endobronchial Blocker Set (August 2, 2016)
  • K152251 — Endobronchial Tube (June 10, 2016)