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FDA 510(k)

MADETT

K-Number: K021044 · 2002-09-11

ApplicantWolfe Tory Medical, Inc.
Decision Date2002-09-11
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MADETT is the device name listed in this FDA 510(k) record. The listed applicant is Wolfe Tory Medical, Inc.. It received FDA 510(k) clearance on 2002-09-11 under 510(k) number K021044. 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 MADETT?

MADETT is a medical device that received FDA 510(k) clearance on 2002-09-11. The listed applicant is Wolfe Tory Medical, Inc.. The 510(k) number is K021044.

When did MADETT receive FDA 510(k) clearance?

MADETT received FDA 510(k) clearance on 2002-09-11, under 510(k) number K021044.

Who is the listed applicant for MADETT?

The FDA 510(k) record lists Wolfe Tory Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MADETT?

The FDA product code for MADETT is BTR.

Related Clinical Trials

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Other records listing Wolfe Tory Medical, Inc. 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.

K002255LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)K990556ESOPHAGEAL INTUBATION DETECTORK945745ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)K942628ESOPHAGEAL INTUBATION DETECTOR BULB

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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