Principal® Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter

Primary DI

06935456210687

Basic UDI-DI Code

69354562PLYL06XM

Reference

FA06001-207

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Princeton Medical Scientific Co.,Ltd

The Peripheral Arteries (PTA) Dilatation Catheter is a Peripheral Dilatation Catheter designed for entire guidewire exchange. Balloon diameters range from 1.5mm to 10.0mm,and the balloon length range from 20 to 210. The balloon material is made of a semi-compliant nylon material for diameter 1.5mm to 10.0mm with a rated burst pressure of 14 atmospheres(FA06001-01~FA06001-113) and 22 atmospheres(FA06001-114~FA06001-133\FA06001-203~FA06001-222). The proximal shaft joins with a luer hub. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.018 inch or 0.035 inch guide wire. Two markers mounted on the balloon shoulder indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.The design of this peripheral dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The Basic UDI-DI associated with this device has 151 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).