Aegisy
Basic Information
- Primary DI
- 06938370123026
- Basic UDI-DI Code
- B-06938370123026
- Reference
- XJLX3260
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
Additional Description
The AegisyTM Vena Cava Filter is laser cut from a nickel titanium alloy (Nitinol) tube and then shaped into an asymmetric lantern-looking configuration, with a distal (cranial) basket in a six diamond shape and the a proximal (caudal) entry basket in a โYโ shape. This design guarantees optimal clot trapping. There is one nut with screw respectively at the Cranial and the Caudal to connect with Delivery Cable in order to controlled release by femoral access or jugular access. The distal basket is connected by six straight struts with the proximal entry basket. Six securing anchors, which fix the AegisyTM filter to the vessel wall, are located on the joint of the proximal entry basket and the six straight struts. A withdrawal hook for withdrawal of the filter into a 10F sheath with a snare kit in case of a temporary implantation is attached to rear end of the proximal entry basket.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C01050102 | VENA CAVA FILTERS, PERMANENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2107231DE01 | DEKRA Certification B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).