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510(k) K181880

VivaSight-SL (TVT) system by Etview , Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2018
Date Received
July 13, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Etview , Ltd.

  • K181886 — VivaSight-DL System (November 14, 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)

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  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)