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510(k) Data Aggregation
K Number
K143652Device Name
Vector PTA Balloon Dilatation Catheter
Manufacturer
Date Cleared
2015-02-26
(65 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Vector Corporation LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector" Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
Device Description
The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon.
The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.
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