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510(k) Data Aggregation
K Number
K192324Device Name
Sheridan Spiral-Flex Endotracheal Tubes
Manufacturer
Date Cleared
2019-12-06
(101 days)
Product Code
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
TeleflexMedical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.
Device Description
The Sheridan Spiral-Flex Endotracheal Tubes are spiral tracheal tubes that are inserted into the trachea via the mouth or the nose in order to establish a patent airway to allow ventilation. The subject device are sterile, single use devices. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. Each tracheal tube is supplied with an appropriately sized 15mm connector.
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