Mozec™ PTA 0.014" OTW

Primary DI

18904224917238

Basic UDI-DI Code

B-18904224917238

Reference

MO14050050B

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 is a sterile, single use, standard Over the Wire (OTW) PTA Catheter which consists of a semi-compliant inflatable balloon, a distal tip (soft tip), and dual lumen shaft design. One lumen provides guidewire (≤ 0.014”) access for advancement of the catheter through the artery and across the lesion and second lumen is for inflation and deflation of the balloon during the procedure. There are two radiopaque Platinum-Iridium marker bands on balloon segment to facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec PTA 0.014” OTW balloon's working length during the procedure. The balloon is bonded distally to a distal tip (soft tip) and proximally to the dual lumen proximal shaft. A hydrophilic coating is applied to the balloon and extends proximally up to part of proximal shaft to enhance insertion and withdrawal performance. The balloon is folded to achieve a low profile. A protective sheath is placed over the balloon to prevent any inadvertent damage to the balloon before use and also to retain the balloon profile.

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