K Number
K964369
Device Name
TRACH CARE SET WITH MICROBAN
Date Cleared
1997-02-11

(102 days)

Product Code
Regulation Number
868.6810
AI/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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