FDA 510(k)

Disposable Endotracheal tube, sterile, AccuCuff

Numéro K : K160694 · 2017-04-07

DemandeurTianjin Medis Medical Device Co., Ltd.

Date de décision2017-04-07

Code produitBTR

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Endotracheal tube, sterile, AccuCuff is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K160694. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Endotracheal tube, sterile, AccuCuff?

Disposable Endotracheal tube, sterile, AccuCuff is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K160694.

When did Disposable Endotracheal tube, sterile, AccuCuff receive FDA 510(k) clearance?

Disposable Endotracheal tube, sterile, AccuCuff received FDA 510(k) clearance on 2017-04-07, under 510(k) number K160694.

Who is the listed applicant for Disposable Endotracheal tube, sterile, AccuCuff?

The FDA 510(k) record lists Tianjin Medis Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endotracheal tube, sterile, AccuCuff?

The FDA product code for Disposable Endotracheal tube, sterile, AccuCuff is BTR.

Essais cliniques associés

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Autres dossiers indiquant Tianjin Medis Medical Device Co., Ltd. en tant que demandeur

K190274Endotracheal Tube K182548Accucuff Indicateur de Pression de Manchon

Dispositifs connexes (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 K243579Cathéter de ventilation 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

Source officielle

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