| EMDDB code |
23984
|
| Basic UDI-DI |
00195451C2AIVLIP49
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
C01040199 Cardiac angiography devices - other
|
| Risk class |
III
|
| Appliance |
-
|
| Device name (in Estonian) |
Pärgarteri IVL-kateeter Shockwave C2 Aero
|
| Device name (in English) |
Shockwave C2 Aero Coronary IVL Catheter
|
| Intended use (is Estonian) |
Pärgarteri IVL-süsteem Shockwave C2 Aero on mõeldud kaltsifitseerunud stenooside (sealhulgas selliste kaltsifitseerunud stenooside, mille puhul võib eeldada vastupanu täielikule balloondilatatsioonile või sellele
järgnevale pärgarteristendi ühtlasele laiendamisele) raviks.
|
| Intended use (in English) |
The Shockwave C2 Aero Coronary IVL System is intended to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion.
|
| Type/model/article number |
C2AIVLIP2512 (2.5 x 12 mm) , C2AIVLIP3012 (3.0 x 12 mm), C2AIVLIP3512 (3.5 x 12 mm), C2AIVLIP4012 (4.0 x 12 mm)
|
| Notified body |
2797
|
| Manufacturer |
Shockwave Medical Inc.
|
| Authorised representative |
ICON (LR) Limited
|
| In register from |
04/30/2026
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
