FDA 510(k)

DISPOSABLE CUFFED ENDOTRACHEAL TUBE

K-Number: K925781 · 1993-04-19

Decision Date1993-04-19

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CUFFED ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Coast Medical Corp.. It received FDA 510(k) clearance on 1993-04-19 under 510(k) number K925781. 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 DISPOSABLE CUFFED ENDOTRACHEAL TUBE?

DISPOSABLE CUFFED ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1993-04-19. The listed applicant is Coast Medical Corp.. The 510(k) number is K925781.

When did DISPOSABLE CUFFED ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

DISPOSABLE CUFFED ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1993-04-19, under 510(k) number K925781.

Who is the listed applicant for DISPOSABLE CUFFED ENDOTRACHEAL TUBE?

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

What is the FDA product code for DISPOSABLE CUFFED ENDOTRACHEAL TUBE?

The FDA product code for DISPOSABLE CUFFED ENDOTRACHEAL TUBE is BTR.

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Other records listing Coast Medical Corp. as applicant

K930929ESOPHAGEAL STETHOSCOPE K930930COAST MEDICAL, INC. RECTAL PROBE K925855DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE K921077DISPOSABLE INTUBATION KITS K921353NASOPHARYNGEAL AIRWAY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.