FDA 510(k)

CUFFED TRACHEAL TUBE (MULTIPLE)

K-Number: K871204 · 1987-04-21

Decision Date1987-04-21

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CUFFED TRACHEAL TUBE (MULTIPLE) 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 1987-04-21 under 510(k) number K871204. 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 CUFFED TRACHEAL TUBE (MULTIPLE)?

CUFFED TRACHEAL TUBE (MULTIPLE) is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K871204.

When did CUFFED TRACHEAL TUBE (MULTIPLE) receive FDA 510(k) clearance?

CUFFED TRACHEAL TUBE (MULTIPLE) received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871204.

Who is the listed applicant for CUFFED TRACHEAL TUBE (MULTIPLE)?

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 CUFFED TRACHEAL TUBE (MULTIPLE)?

The FDA product code for CUFFED TRACHEAL TUBE (MULTIPLE) is BTR.

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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

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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

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