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K Number
K213915
Device Name
BIB Stent Placement Catheter
Manufacturer
NuMED Inc.
Date Cleared
2022-01-12

(28 days)

Product Code
NVM
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
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.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).