FDA 510(k)

MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE

K-Number: K080821 · 2008-04-22

Decision Date2008-04-22

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2008-04-22 under 510(k) number K080821. 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 MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE?

MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K080821.

When did MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE received FDA 510(k) clearance on 2008-04-22, under 510(k) number K080821.

Who is the listed applicant for MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE?

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

What is the FDA product code for MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE?

The FDA product code for MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE is BTR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kimberly-Clark Corp. as applicant

K131879KC 300 SURGICAL MASK K131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE K120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING K112805KIMGUARD ONE-STEP STERILIZATION WRAP K113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

View all 102 devices →

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.