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510(k) Data Aggregation
K Number
K031794Device Name
ENDOFLEX TRACHEAL TUBE
Manufacturer
MERLYN ASSOCIATES INC.
Date Cleared
2004-03-12
(276 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
MERLYN ASSOCIATES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.
Device Description
The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways: The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate intubation. The flexing tip eliminates the need for intubation stylets.
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