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510(k) Data Aggregation
K Number
K021044Device Name
MADETT
Manufacturer
WOLFE TORY MEDICAL, INC.
Date Cleared
2002-09-11
(163 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
WOLFE TORY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway. To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
Device Description
The Endotracheal Mucosal Atomization Device (MADett) is a disposable, sterile device that converts a topical solution into a fine particle spray for application into the trachea bevond the ETT. The clinician connects the device in line between the endotracheal tube and the ventilation device. The clinician then attaches a syringe of topical medication to the luer lock fitting of the atomizer and delivers medications into the trachea while simultaneously ventilating the patient.
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K Number
K002255Device Name
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
Manufacturer
WOLFE TORY MEDICAL, INC.
Date Cleared
2000-09-18
(55 days)
Product Code
CCT
Regulation Number
868.5170Why did this record match?
Applicant Name (Manufacturer) :
WOLFE TORY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990556Device Name
ESOPHAGEAL INTUBATION DETECTOR
Manufacturer
WOLFE TORY MEDICAL, INC.
Date Cleared
1999-03-26
(32 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
WOLFE TORY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.
Device Description
A device that relies on anatomical differences between the trachea and the esophagus. By applying negative pressure to the endotracheal tube, the rigid trachea remains open allowing free aspiration of air into the EDD, whereas the fibromuscular esophagus collapses around the endotracheal tube and thus prevents aspiration of air.
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