|
MSA code |
16551
|
Basic UDI-DI |
|
Seadme klass |
Meditsiiniseade
|
Medical Device Nomenclature |
|
Risk class |
III
|
Appliance |
-
|
Device name (in Estonian) |
SCEPTER XC™ okludeeriv balloonkateeter
|
Device name (in English) |
SCEPTER XC™ Occlusion Balloon Catheter
|
Intended use (is Estonian) |
Kasutamiseks perifeerses ja neurovereringesüsteemis, kus soovitakse tekitada ajutistokludeerimist. Balloonkateetrid võimaldavad ajutist okludeerimist verevoolu valikuliseks
peatamiseks või juhtimiseks. Balloonkateetrid võimaldavad samuti ballooni abil ntrakraniaalsete aneurüsmide emboliseerimist. Kasutamiseks perifeerses vereringesüsteemis diagnostiliste agentide,
näiteks kontrastaine, ja terapeutiliste agentide, näiteks embolisatsiooniaine infusiooniks
|
Intended use (in English) |
For use in the peripheral and neuro vasculature where temporary occlusion is desired.
The balloon catheters provide temporary vascular occlusion which is useful in
selectively stopping or controlling blood flow. The balloon catheters also offer balloon
assisted embolization of intracranial aneurysms.
For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents such as embolization materials.
|
Type/model/article number |
BC0411XC
|
Notified body |
0297
|
Manufacturer |
MicroVention, Inc.
|
Authorised representative |
MicroVention Europe
|
In register from |
05/03/2021
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
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