FDA 510(k)

BRANDT TRACHEAL TUBE(TENTATIVE)

K-Number: K852025 · 1985-08-13

Decision Date1985-08-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BRANDT TRACHEAL TUBE(TENTATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K852025. 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 BRANDT TRACHEAL TUBE(TENTATIVE)?

BRANDT TRACHEAL TUBE(TENTATIVE) is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K852025.

When did BRANDT TRACHEAL TUBE(TENTATIVE) receive FDA 510(k) clearance?

BRANDT TRACHEAL TUBE(TENTATIVE) received FDA 510(k) clearance on 1985-08-13, under 510(k) number K852025.

Who is the listed applicant for BRANDT TRACHEAL TUBE(TENTATIVE)?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRANDT TRACHEAL TUBE(TENTATIVE)?

The FDA product code for BRANDT TRACHEAL TUBE(TENTATIVE) 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 Mallinckrodt Critical Care as applicant

K880343BURNEY GALLBLADDER CATHETER KIT K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR K874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE K874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

View all 92 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.