FDA 510(k)

POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

K-Number: K920900 · 1992-03-18

Decision Date1992-03-18

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1992-03-18 under 510(k) number K920900. 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 POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES?

POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Polamedco, Inc.. The 510(k) number is K920900.

When did POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES receive FDA 510(k) clearance?

POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES received FDA 510(k) clearance on 1992-03-18, under 510(k) number K920900.

Who is the listed applicant for POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES?

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

What is the FDA product code for POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES?

The FDA product code for POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES is BTR.

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Other records listing Polamedco, Inc. 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

View on FDA Database →

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