Ekisu
Basic Information
- Primary DI
- 18904224938592
- Basic UDI-DI Code
- B-18904224938592
- Reference
- EKS6F
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
The Ekisuโข - Aspiration Catheter is a dual lumen, rapid exchange catheter provided with related accessories which include suction syringe, a stopcock, and extension tube. The Rx (Rapid exchange) port (10mm in length) is compatible with 0.014โ (0.36mm) guide wires. The proximal end of catheter is equipped with standard luer hub to facilitate the accessories provided. The larger extraction lumen comes pre-loaded with a stylet that resists kinking during delivery. The stylet is removed prior to the extraction of fresh, soft emboli and thrombi by aspiration. The distal shaft (350mm length and 1.30mm OD) of the catheter has a hydrophilic coating on 300mm length from the distal tip. The distal tip facilitates advancement of the catheter to and through the stenosis. Radiopaque marker band is incorporated on the distal tip which provides fluoroscopic visualization of catheter when inserted into the body. The aspiration catheter model is available in 6F size according to the guide catheter compatibility and a working length of 140cm, allowing delivery through standard 6F guide catheter.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010401020501 | MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 11125-2017-CE-IND-NA-PS | DNV Product Assurance AS | Expired |
| MDD Annex II (excluding section 4) | 11124-2017-CE-IND-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).