Identification of the person placing the product on the market
DEVIMED Ltd.
EIK
130322047
BG
SOF
Sofia
ALEXANDER MAZHAROV
+35929533616
devimed@abv.bg
Identification of the wholesaler
DEVIMED Ltd.
EIK
130322047
BG
SOF
Sofia
ALEXANDER MAZHAROV
+35929533616
devimed@abv.bg
IV-P-T/МИ-180
10/12/2007
General medical information about the device
10 - Single-use devices
Class ІІ a
Cardiovascular system
UMDNS
17184
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.
