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510(k) K082420

TRACHEOSCOPIC VENTILATION TUBE (TVT) by Etview — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
August 22, 2008
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

  • K181880 — VivaSight-SL (TVT) system (November 29, 2018)
  • 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)
  • K052233 — TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM (December 13, 2005)

Other clearances for product code BTR

  • K250173 — Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE T (October 6, 2025)
  • K243785 — Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye S (September 25, 2025)
  • K243579 — AeroJet Ventilation Catheter (August 13, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K242495 — LMA Fastrach ETT SU (April 29, 2025)
  • K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); (February 11, 2025)
  • 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)