MozecTM PTA 0.014"Rx

Primary DI

18904224905129

Basic UDI-DI Code

B-18904224905129

Reference

MR14035030B

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

The Mozec™ PTA Balloon Dilatation Catheter (Rx 0.014”) is a "Rapid exchange" type catheter and consists of a Balloon (dilatation element) near the distal tip with double radiopaque marker bands which represent the approximate balloon working length at nominal pressure. The radiopaque markers ensure the accurate positioning of the balloon in the stenosis under fluoroscopy. The hypo tube shaft has a luer-lock connector (hub) for balloon inflation at its proximal end. The catheter has a soft tip which facilitates advancement of the catheter to and through the stenosis. The two coaxial lumens permit movement of guide wire and balloon inflation. Two markers are located on the proximal shaft at 90 and 100 cm from the distal tip to indicate catheter position. The proximal portion of the shaft has PTFE Coating while distal portion of the shaft has hydrophilic coating applied on it, in order to optimize proximal pushability with a smooth transition to distal shaft trackability. The guidewire access port is located at the soft tip of the catheter while the exit port (rapid exchange) is located 25cm away from the tip of the balloon. The compliance chart on the inner and outer label indicates change in balloon diameter for a given change in pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. -Guide wire compatibility: 0.014” - 0.014” Rx PTA Balloon Dilatation Catheter available with usable length of 150 cm. The Mozec™ PTA Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub.

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