FDA 510(k)

VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE

K-Number: K960795 · 1996-05-22

Decision Date1996-05-22

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 1996-05-22 under 510(k) number K960795. 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 VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE?

VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1996-05-22. The listed applicant is Vygon Corp.. The 510(k) number is K960795.

When did VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1996-05-22, under 510(k) number K960795.

Who is the listed applicant for VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE?

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

What is the FDA product code for VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE?

The FDA product code for VYGON DOUBLE LUMEN 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.

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 Vygon Corp. as applicant

K121105NUTRISAFE 2 FEEDING TUBE K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX K073493HEPATOSTAT SET K070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 K061796HEPATOSTAT SET, MODEL 760X K061250MULTICATH EXPERT

View all 48 devices →

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.