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FDA 510(k)

TRACHEOSCOPIC VENTILATION TUBE (TVT)

K-Number: K082420 · 2008-10-08

ApplicantEtview
Decision Date2008-10-08
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEOSCOPIC VENTILATION TUBE (TVT) is the device name listed in this FDA 510(k) record. The listed applicant is Etview. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082420. 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)?

TRACHEOSCOPIC VENTILATION TUBE (TVT) is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Etview. The 510(k) number is K082420.

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

TRACHEOSCOPIC VENTILATION TUBE (TVT) received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082420.

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

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

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

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

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Related Devices (Code: BTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ 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, LLCK243785Shiley™ 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, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova 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

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

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