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FDA 510(k)

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE

K-Number: K954750 · 1995-12-08

ApplicantUnomedical Sdn Bhd
Decision Date1995-12-08
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical Sdn Bhd. It received FDA 510(k) clearance on 1995-12-08 under 510(k) number K954750. 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 PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE?

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1995-12-08. The listed applicant is Unomedical Sdn Bhd. The 510(k) number is K954750.

When did PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1995-12-08, under 510(k) number K954750.

Who is the listed applicant for PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE?

The FDA 510(k) record lists Unomedical Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE?

The FDA product code for PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE is BTR.

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Other records listing Unomedical Sdn Bhd 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.

K973076EUROMEDICAL HAEMATURIA FOLEY CATHETERK962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEK954751SILICONE ENDOTRACHEAL TUBEK954754WIRE REINFORCED SILICONE ENDOTRACHEAL TUBEK954753PEDIATRIC SILICONE ENDOTRACHEAL TUBEK951696ENDOTRACHEAL TUBE

View all 9 devices →

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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