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FDA 510(k)

WELL LEAD ENDOTRACHEAL TUBE

K-Number: K042683 · 2005-02-18

ApplicantWell Lead Medical Instruments
Decision Date2005-02-18
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WELL LEAD ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Instruments. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K042683. 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 WELL LEAD ENDOTRACHEAL TUBE?

WELL LEAD ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Well Lead Medical Instruments. The 510(k) number is K042683.

When did WELL LEAD ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

WELL LEAD ENDOTRACHEAL TUBE received FDA 510(k) clearance on 2005-02-18, under 510(k) number K042683.

Who is the listed applicant for WELL LEAD ENDOTRACHEAL TUBE?

The FDA 510(k) record lists Well Lead Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELL LEAD ENDOTRACHEAL TUBE?

The FDA product code for WELL LEAD ENDOTRACHEAL TUBE is BTR.

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Other records listing Well Lead Medical Instruments 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.

K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSK073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEK042684WELL LEAD TRACHEOSTOMY TUBE

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.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.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 Aps

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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