FDA 510(k)

ENDOTRACHEAL TUBE, ACCESSORY

K-Number: K862347 · 1986-07-11

Decision Date1986-07-11

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ENDOTRACHEAL TUBE, ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Sheridan Catheter Corp.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862347. 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 ENDOTRACHEAL TUBE, ACCESSORY?

ENDOTRACHEAL TUBE, ACCESSORY is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Sheridan Catheter Corp.. The 510(k) number is K862347.

When did ENDOTRACHEAL TUBE, ACCESSORY receive FDA 510(k) clearance?

ENDOTRACHEAL TUBE, ACCESSORY received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862347.

Who is the listed applicant for ENDOTRACHEAL TUBE, ACCESSORY?

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

What is the FDA product code for ENDOTRACHEAL TUBE, ACCESSORY?

The FDA product code for ENDOTRACHEAL TUBE, ACCESSORY is BTR.

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Other records listing Sheridan Catheter Corp. as applicant

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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.