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FDA 510(k)

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

K-Number: K093135 · 2010-04-02

ApplicantVenner Medical (Singapore) Pte, Ltd.
Decision Date2010-04-02
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K093135. 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 VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE?

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K093135.

When did VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE receive FDA 510(k) clearance?

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE received FDA 510(k) clearance on 2010-04-02, under 510(k) number K093135.

Who is the listed applicant for VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE?

The FDA 510(k) record lists Venner Medical (Singapore) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE?

The FDA product code for VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE is BTR.

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Other records listing Venner Medical (Singapore) Pte, Ltd. 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.

K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmK192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mmK191602APA Oxy BladeK110631VENNER TRACHEAL SEAL MONITORK100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE

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

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

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