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FDA 510(k)

Endotracheal tube; Reinforced Endotracheal tube

K-Number: K170234 · 2018-01-17

ApplicantZhanjiang Star Enterprise Co., Ltd.
Decision Date2018-01-17
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

NCT07682480Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without StyletNOT_YET_RECRUITING

Other records listing Zhanjiang Star Enterprise Co., 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.

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

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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