K Number
K961707Device Name
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
Manufacturer
Date Cleared
1997-03-11
(313 days)
Product Code
Regulation Number
868.6810AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
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