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| EMDDB code |
20697
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| Basic UDI-DI |
07540184F3000ZW
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| Seadme klass |
Meditsiiniseade
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| Medical Device Nomenclature |
|
| Risk class |
III
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| Appliance |
-
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| Device name (in Estonian) |
SavvyWire Eelvormitud rõhu-juhtetraat
|
| Device name (in English) |
Savvywire Pre-shaped Pressure Guidewire
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| 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.
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| 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.
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| Type/model/article number |
F3001, F3002
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| Notified body |
2797
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| Manufacturer |
Opsens Inc.
|
| Authorised representative |
MDSS GmbH
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| In register from |
06/20/2024
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| Entry status |
Active
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| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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