Mesire™

Primary DI

18904224901473

Basic UDI-DI Code

B-18904224901473

Reference

MSB60017

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

Mesire™ Sinus Balloon catheter is a “Over The Wire” type catheter with an integrated shaft system and a low profile balloon (dilatation element) which is bonded distally to the inner lumen and proximally to distal shaft. The system is having dual lumen. One lumen is used for inflation of the balloon with saline, and the second provides passage of a Sinus Light Wire to facilitate advancement of the Sinus Balloon Catheter to the target. The proximal end of inner lumen is assembled to a Luer hub at its proximal end. The distal shaft, hypo tube, strain relief are bonded to the hub from the proximal end of the hub respectively. The main port of Hub permits the use of light wire and Lateral port for balloon inflation / deflation. Three endoscopic markers present on the distal shaft of the balloon catheter helps in accurate positioning of the balloon under endoscopy. Three visual markers present on the hypo tube helps in positioning the balloon catheter with respect to Sinus Guide catheter. The first distal visual marker on hypo tube indicated that the tip of the balloon catheter is in the straight section of the sinus guide catheter. Second and third visual markers on hypo tube corresponds to the exit of the balloon from the sinus guide catheter.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).