FDA 510(k)

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)

K-Number: K080339 · 2008-10-27

Decision Date2008-10-27

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) is the device name listed in this FDA 510(k) record. The listed applicant is Medsource International, LLC. It received FDA 510(k) clearance on 2008-10-27 under 510(k) number K080339. 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 MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)?

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) is a medical device that received FDA 510(k) clearance on 2008-10-27. The listed applicant is Medsource International, LLC. The 510(k) number is K080339.

When did MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) receive FDA 510(k) clearance?

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) received FDA 510(k) clearance on 2008-10-27, under 510(k) number K080339.

Who is the listed applicant for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)?

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

What is the FDA product code for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)?

The FDA product code for MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) 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.

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

Other records listing Medsource International, LLC as applicant

K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter K120424MEDSOURCE IV ADMINSTRATION SET K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

Related Devices (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 K243579AeroJet Ventilation CatheterPipeline 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

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.