Device Name
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSManufacturer
Date Cleared
2009-06-29
(26 days)
Product Code
Regulation Number
892.5700Type
SpecialPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A