DEVICE DETAILS
| NAME OF DEVICE | CORONARY DILATATION CATHETER-NON-COMPLIANT |
|---|---|
| ESTABLISHMENT NAME | MITSU SCIENTIFIC SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GD1219420-41771 |
| BRAND NAME | NC-TADPOLE |
| MEDICAL DEVICE CATEGORY | MD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Coronary dilatation catheter provided by Lepu medical has two types, semi-compliant balloon dilation catheter and non-compliant balloon dilation catheter. NC TadpoleTM is non-compliant balloon dilation catheter. The noncompliant balloon material allows higher dilation pressure than semi-compliant material. According to EN ISO 10555-1:2013, Coronary Dilatation Catheter is coated with hydrophilic coating which is activated when wet. That’s to say it is hydrophilic intravascular catheter. |
| DEVICE INTENDED PURPOSE | Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; -Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; |
| VALIDITY DATE OF REGISTRATION | 02/04/2020 - 01/04/2025 |