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FDA 510(k)

ENDOFLEX TRACHEAL TUBE

K-Number: K031794 · 2004-03-12

ApplicantMerlyn Associates, Inc.
Decision Date2004-03-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDOFLEX TRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Merlyn Associates, Inc.. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K031794. 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 ENDOFLEX TRACHEAL TUBE?

ENDOFLEX TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Merlyn Associates, Inc.. The 510(k) number is K031794.

When did ENDOFLEX TRACHEAL TUBE receive FDA 510(k) clearance?

ENDOFLEX TRACHEAL TUBE received FDA 510(k) clearance on 2004-03-12, under 510(k) number K031794.

Who is the listed applicant for ENDOFLEX TRACHEAL TUBE?

The FDA 510(k) record lists Merlyn Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOFLEX TRACHEAL TUBE?

The FDA product code for ENDOFLEX TRACHEAL TUBE is BTR.

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Other records listing Merlyn Associates, Inc. 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.

K062644FLEXWARMER, MODELS KZ-1 AND KZ-2

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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