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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

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
Documents related to medical device model
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