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FDA 510(k)

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet

K-Number: K172208 · 2018-02-16

ApplicantNevap, Inc.
Decision Date2018-02-16
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is a medical device manufactured by Nevap, Inc.. It received FDA 510(k) clearance on 2018-02-16 under approval number K172208. 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 NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Nevap, Inc.. The 510(k) number is K172208.

When was NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet approved by the FDA?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet received FDA 510(k) clearance on 2018-02-16, under approval number K172208.

What company makes NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is manufactured by Nevap, Inc..

What is the FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

The FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is BTR.

Related Clinical Trials

NCT07586592 Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing RECRUITING NCT07568743 ProVu Video Stylet With Versus Without the Fekry Airway RECRUITING NCT06231342 Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion RECRUITING

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.

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.

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