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K Number
K010016
Device Name
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
Manufacturer
COOK, INC.
Date Cleared
2001-10-09

(280 days)

Product Code
BWC
Regulation Number
868.5090
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5090 Emergency airway needle.

(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).