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510(k) Data Aggregation
K Number
K213915Device Name
BIB Stent Placement CatheterManufacturer
Date Cleared
2022-01-12
(28 days)
Product Code
Regulation Number
870.1250Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Indicated for CP Stent / Covered CP Stent and G-Armor Covered Stent placement in vessels over 8mm in diameter
Device Description
Not Found
AI/ML Overview
This document, K213915, is a 510(k) clearance letter for the NuMED Inc. BIB Stent Placement Catheter. It is not a study report or a document that details acceptance criteria and device performance based on a study.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document primarily focuses on the FDA's decision regarding the device's substantial equivalence and outlines regulatory requirements.
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