Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130142Device Name
FLIXENE IFG VASCULAR GRAFTManufacturer
Date Cleared
2013-03-15
(52 days)
Product Code
Regulation Number
870.3450Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Atrium Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a vascular graft. It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML device. Therefore, I cannot fulfill your request based on the given input.
Ask a Question
Ask a specific question about this device
Page 1 of 1