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510(k) Data Aggregation
K Number
K173423Device Name
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
Manufacturer
Date Cleared
2017-11-17
(16 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
Nano4Imaging GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
Device Description
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
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K Number
K160594Device Name
MRWire Guide Wire
Manufacturer
Date Cleared
2016-11-22
(266 days)
Product Code
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
NANO4IMAGING GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
Device Description
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.
Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
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Ask a specific question about this device
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