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FDA 510(k)

Sheridan Spiral-Flex Endotracheal Tubes

K-Number: K192324 · 2019-12-06

ApplicantTeleflexmedical, Inc.
Decision Date2019-12-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sheridan Spiral-Flex Endotracheal Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K192324. 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 Sheridan Spiral-Flex Endotracheal Tubes?

Sheridan Spiral-Flex Endotracheal Tubes is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K192324.

When did Sheridan Spiral-Flex Endotracheal Tubes receive FDA 510(k) clearance?

Sheridan Spiral-Flex Endotracheal Tubes received FDA 510(k) clearance on 2019-12-06, under 510(k) number K192324.

Who is the listed applicant for Sheridan Spiral-Flex Endotracheal Tubes?

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

What is the FDA product code for Sheridan Spiral-Flex Endotracheal Tubes?

The FDA product code for Sheridan Spiral-Flex Endotracheal Tubes is BTR.

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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

View on FDA Database →

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

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