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FDA 510(k)

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)

K-Number: K801005 · 1980-05-23

ApplicantNational Catheter Co. Div. Mallinckrodt
Decision Date1980-05-23
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) is the device name listed in this FDA 510(k) record. The listed applicant is National Catheter Co. Div. Mallinckrodt. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K801005. 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 MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)?

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is National Catheter Co. Div. Mallinckrodt. The 510(k) number is K801005.

When did MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) receive FDA 510(k) clearance?

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) received FDA 510(k) clearance on 1980-05-23, under 510(k) number K801005.

Who is the listed applicant for MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)?

The FDA 510(k) record lists National Catheter Co. Div. Mallinckrodt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)?

The FDA product code for MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) is BTR.

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Other records listing National Catheter Co. Div. Mallinckrodt 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.

K802918ANTHRON CATHETER SETK802505DOUBLE LUMEN TRACHEAL TUBEK810321REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)K801924HI-LO TEMP GEN. PURPOSE TEMP. PROBEK791190STETHOSCOPE WITH TEMPERATURE SENSORK781665TUBE, LEATHERMAN/IMBRUCE

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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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