Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

Fustar

Lifetech Scientific (Shenzhen) Co., Ltd. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
06938370116301
Basic UDI-DI Code
B-06938370116301
Reference
SVA7F-900
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

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
MDD Annex II (excluding section 4) 2107231CE01

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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