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510(k) Data Aggregation
K Number
K010853Device Name
GUIDER SOFTIP GUIDING CATHETER XF 5FManufacturer
Date Cleared
2001-04-18
(28 days)
Product Code
Regulation Number
870.1250Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
GUIDER SOFTIP GUIDING CATHETER XF 5F
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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