Fustar
Basic Information
- Primary DI
- 06938370116288
- Basic UDI-DI Code
- B-06938370116288
- Reference
- SVA7F-550
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
Additional Description
The FustarTM Steerable Introducer is designed to perform as a guiding sheath and/or introducer sheath, and the introducer is a single-use percutaneous accessory for deploying and retrieving devices in patients vessel. The introducer is available with a radiopaque band/tip incorporated within the sheath material to identify the location of the sheaths distal tip. The FustarTM Steerable Introducers low-profile design and atraumatic tip reduce the potential for trauma during transseptal punctures while facilitating passage of a wide variety of catheters and devices. By combining a low profile with high-tech capabilities, the FustarTM Steerable Introducer gives physicians greater control during the procedures. Curl options include type A (25.0 mm) and type B (50.0 mm). The usable length can be 550mm, 700mm, 800mm and 900mm. The introducer set is composed of steerable sheath, dilator, loader, haemostatic valve and delivery cable. The introducer allows a device to be advanced to the desired or hard-to-reach position and it facilitates delivery, deployment and retrieval of the interventional devices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0780 | VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2107231CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).