FDA 510(k)

Endotracheal tube; Reinforced Endotracheal tube

Numéro K : K170234 · 2018-01-17

DemandeurZhanjiang Star Enterprise Co., Ltd.

Date de décision2018-01-17

Code produitBTR

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Endotracheal tube; Reinforced Endotracheal tube is the device name listed in this FDA 510(k) record. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K170234. 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 Endotracheal tube; Reinforced Endotracheal tube?

Endotracheal tube; Reinforced Endotracheal tube is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. The 510(k) number is K170234.

When did Endotracheal tube; Reinforced Endotracheal tube receive FDA 510(k) clearance?

Endotracheal tube; Reinforced Endotracheal tube received FDA 510(k) clearance on 2018-01-17, under 510(k) number K170234.

Who is the listed applicant for Endotracheal tube; Reinforced Endotracheal tube?

The FDA 510(k) record lists Zhanjiang Star Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endotracheal tube; Reinforced Endotracheal tube?

The FDA product code for Endotracheal tube; Reinforced Endotracheal tube is BTR.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Zhanjiang Star Enterprise Co., Ltd. en tant que demandeur

K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.