FDA 510(k)

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM

K-Number: K052233 · 2005-12-13

Decision Date2005-12-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K052233. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM?

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Etview , Ltd.. The 510(k) number is K052233.

When did TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM receive FDA 510(k) clearance?

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM received FDA 510(k) clearance on 2005-12-13, under 510(k) number K052233.

Who is the listed applicant for TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM?

The FDA 510(k) record lists Etview , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM?

The FDA product code for TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM is BTR.

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Other records listing Etview , Ltd. as applicant

K181880VivaSight-SL (TVT) system K181886VivaSight-DL System K152438ETView VivaSight-SL (TVT) system K123853VIVASIGHT-DL SYSTEM K121028ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))K120334VIVA EB

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Related Devices (Code: BTR)

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro Robotics K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.