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510(k) K121028

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) by Etview , Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2012
Date Received
April 5, 2012
Clearance Type
Traditional
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.

  • 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)
  • 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 BTR

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  • 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)