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FDA 510(k)

VivaSight-SL (TVT) system

K-Number: K181880 · 2018-11-29

ApplicantEtview , Ltd.
Decision Date2018-11-29
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VivaSight-SL (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 2018-11-29 under 510(k) number K181880. 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 VivaSight-SL (TVT) system?

VivaSight-SL (TVT) system is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Etview , Ltd.. The 510(k) number is K181880.

When did VivaSight-SL (TVT) system receive FDA 510(k) clearance?

VivaSight-SL (TVT) system received FDA 510(k) clearance on 2018-11-29, under 510(k) number K181880.

Who is the listed applicant for VivaSight-SL (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 VivaSight-SL (TVT) system?

The FDA product code for VivaSight-SL (TVT) system is BTR.

Other records listing Etview , Ltd. as applicant

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.

K181886VivaSight-DL SystemK152438ETView VivaSight-SL (TVT) system

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.

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 ApsK250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)Flexicare Medical Limited.

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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