HeartR
Basic Information
- Primary DI
- 08720214007566
- Basic UDI-DI Code
- B-08720214007566
- Reference
- LEFVM05B
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- LifeTech Scientific (Europe) B.V.
Additional Description
The HeartR VSD Occluder is a percutaneous, transcatheter closure device for the non surgical closure of a ventricular septal defect in patients. The occluder is a self expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short cylindrical waist corresponding to the size of the VSD. To increase its closing ability and reduce the re sidual shunts, the discs and waist are filled with PTFE membranes securely sewn to the device by Nylon threads. There are muscular VSD and membranous VSD (type symmetric; type asymmetric; type Eccentric) occluders, which are selected in accordance with the anatomical conditions and/or based on overall medical condition by trained physicians/doctors.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P07040301 | CARDIAC OCCLUDERS, VENTRICULAR SEPTAL DEFECTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2166785CE03&2166785DE08 | DEKRA Certification B.V. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).