Identification of the person placing the product on the market
Identification of the wholesaler
General medical information about the device
10 - Single-use devices
Class ІІ a
Ultraverse 035 PTA Balloon Dilatation Catheter
Description of the medical device
Sterility, Hospital prescription
Intended action by the manufacturer
The Ultraverse® 035 PTA Dilatation Catheter is a semi-compliant balloon catheter consisting of an over the wire (OTW) catheter with an angioplasty balloon fixed at the distal tip.
The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/ or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
BG051PO001-6.2.14 "Creating an electronic database of medical devices, paid with public funds"
The project is funded by the Operational Program "Human Resources Development", co-financed by the European Social Fund of the European Union