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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 20697
Basic UDI-DI 07540184F3000ZW
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class III
Appliance -
Device name (in Estonian) SavvyWire Eelvormitud rõhu-juhtetraat
Device name (in English) Savvywire Pre-shaped Pressure Guidewire
Intended use (is Estonian) SavvyWire on ette nähtud selleks, et sisestada ja paigaldada südamekambritesse interventsiooniseadmeid, sh aordiklapi kateetrikaudse protseduuri jaoks vajalikke seadmeid, ja mõõta samal ajal rõhku südames, mis võimaldab arvutada hemodünaamilisi näitajaid. Lisaks saab SavvyWire’i abil südant ajutiselt seestpoolt stimuleerida, edastades südamesse välise impulsigeneraatori elektrisignaali.
Intended use (in English) The SavvyWire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavvyWire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
Type/model/article number F3001, F3002
Notified body 2797
Manufacturer Opsens Inc.
Authorised representative MDSS GmbH
In register from 06/20/2024
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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