Kulani™ NC

Primary DI

18904224942650

Basic UDI-DI Code

B-18904224942650

Reference

KNM22515

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

Kulani™ NC- Rx PTCA Balloon Dilatation catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. The balloon is folded to achieve a low profile. Radiopaque platinum/iridium marker(s) facilitate fluoroscopic visualization of the proximal and distal ends of the Kulani™ NC balloon's working length. The outer lumen of the distal shaft is used for inflation and deflation of the balloon and the inner lumen provides guide wire (≤ 0.014") access for advancement of the catheter through the artery and across the lesion. The Rx port, located 25 cm proximal to the soft tip, provides an exit port for the guide wire. A hydrophilic coating covers the balloon and extends proximally from the balloon to the Rx port. The proximal shaft has a luer locking hub for balloon inflation/deflation. Two markers on the proximal shaft indicate the catheter position relative to the tip of a brachial (90 cm) or femoral (100 cm) guiding catheter. 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. A stylet is inserted in the inner lumen to prevent kinking or damage to the inner lumen. The protective sheath and the stylet are to be removed prior to use. Kulani™ NC is compatible with ≤0.014" (0.36mm) Guide wires and ≥5F (0.056"/1.42mm) Guiding catheters. The usable length of the Kualni™ NC is 142cm. The Kulani™ NC product range includes balloon diameters ranging from 2.00 mm to 5.00 mm and balloon lengths ranging from 8 mm to 38 mm.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).