CeraFlex
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Basic Information
- Primary DI
- 08720214005593
- Basic UDI-DI Code
- B-08720214005593
- Reference
- LE-PFOf-2518
- 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 CeraFlex PFO Closure System includes CeraFlex PFO Occluder and SteerEaseTMIntroducer. The PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of patent foramen ovale (PFO). The PFO Occluder is self-expandable double discs device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs. PET membranes sewn into each disc helpto seal the hole and provide a foundation for growth of tissue over the occluder after placement. All metallic structures are plated with titanium nitride (TiN) to improve the biocompatibility.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P07040303 | CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT |
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).