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510(k) Data Aggregation
K Number
K162434Device Name
NC Gallant PTCA Catheter
Manufacturer
Date Cleared
2017-01-19
(141 days)
Product Code
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
MEDINOL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NC Gallant PTCA Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.
Device Description
The NC Gallant is a sterile, single-use, intravascular medical device. The NC Gallant is a double lumen catheter comprising an expandable non-compliant (NC) coronary balloon on a rapid exchange (RX) catheter.
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K Number
K150487Device Name
X-Suit NIR Biliary Metallic Stent
Manufacturer
Date Cleared
2016-02-12
(352 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDINOL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The X-Suit NIR® Biliary Metallic Stent is indicated for palliation of malignant strictures in the biliary tre.
Device Description
Not Found
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K Number
K081956Device Name
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
Manufacturer
Date Cleared
2009-01-09
(184 days)
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDINOL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
X-Suit NIR® Biliary Metallic Stent is indicated for the palliation of malignant strictures in the biliary tree.
Device Description
The X-Suit NIR® Biliary Metallic Stent is designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device is comprised of a self-expanding stent, which is pre-loaded on a delivery system. The stent is available in 8 and 10mm labeled diameters, and 40 - 100mm labeled lengths.
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K Number
K002130Device Name
NIR BILIARY STENT
Manufacturer
Date Cleared
2000-10-30
(108 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDINOL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K973171Device Name
NIR BILIARY STENT
Manufacturer
Date Cleared
1998-11-13
(445 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
MEDINOL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NIR Biliary Stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
Device Description
The proposed NIR™ Biliary Stent is a balloon expandable stent designed to be used with a balloon dilatation catheter. The delivery catheter facilitates transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.
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