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510(k) Data Aggregation
K Number
K170635Device Name
Chameleon PTA Balloon Catheter
Manufacturer
AV Medical Technologies Ltd
Date Cleared
2017-03-30
(28 days)
Product Code
LIT, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
AV Medical Technologies Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Device Description
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
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K Number
K163231Device Name
Chameleon PTA Balloon Catheter
Manufacturer
AV Medical Technologies Ltd
Date Cleared
2017-01-17
(61 days)
Product Code
LIT, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
AV Medical Technologies Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Device Description
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
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K Number
K151678Device Name
Chameleon PTA Balloon Catheter
Manufacturer
AV Medical Technologies Ltd
Date Cleared
2015-09-21
(91 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
AV Medical Technologies Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Device Description
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
Ask a Question
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