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510(k) Data Aggregation
K Number
K092863Device Name
MAXIFLO, TAPERFLOManufacturer
Date Cleared
2009-10-08
(21 days)
Product Code
Regulation Number
870.3450Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MAXIFLO, TAPERFLO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Creation of subcutaneous arteriovenous conduits for blood access, bypass or reconstruction of occluded or diseased arterial blood vessels.
Device Description
Not Found
AI/ML Overview
The provided text is a letter from the FDA regarding the clearance of a medical device, Vascutek Maxiflo and Taperflo ePTFE Vascular Prostheses. It is a regulatory document and does not contain any information about acceptance criteria, study details, or device performance data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document. My response is based solely on the provided text.
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