HeartR
Basic Information
- Primary DI
- 08720214006682
- Basic UDI-DI Code
- B-08720214006682
- Reference
- LEFS18
- 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 Atrial Septal Defect (ASD) Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. The system includes the HeartRTM ASD Occluder and the SteerEase Introducer. The HeartR ASD Occluders have two types, HeartRTM ASD Occluder and HeartR Multi-fenestrated (Cribriform) ASD Occluder. The HeartR ASD Occluder is a self-expandable double disc device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs to fit the defect size. PET membranes sewn into each disc and the waist (no PET membrane sewn into the waist for multifenestrated ASD occluder) help to seal the hole and provide a foundation for growth of tissue over the occluder after placement.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P07040302 | CARDIAC OCCLUDERS, ATRIAL 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).