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510(k) Data Aggregation
K Number
K080339Device Name
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
Manufacturer
MEDSOURCE INTERNATIONAL, LLC.
Date Cleared
2008-10-27
(262 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
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Matched: '868.5790'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
Device Description
MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device
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