FDA 510(k)

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

Номер K: K172208 · 2018-02-16

ЗаявительNevap, Inc.

Дата решения2018-02-16

Код продуктаBTR

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Nevap, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K172208. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

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. The listed applicant is Nevap, Inc.. The 510(k) number is K172208.

When did NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet receive FDA 510(k) clearance?

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

Who is the listed applicant for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

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

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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 K243579Катетер вентилирования AeroJetPipeline 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

Официальный источник

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