Mozec™ PTA 0.035" OTW
Basic Information
- Primary DI
- 18906029359121
- Basic UDI-DI Code
- B-18906029359121
- Reference
- MO35060040B
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
Mozec™ PTA OTW Balloon Dilatation Catheter consists of a Balloon (dilatation element) near the distal tip with radiopaque marker bands, which represent the approximate balloon working length at nominal pressure. The proximal end has a Y luer hub for balloon inflation. The catheter has a soft tip at the distal end. Dual lumens shaft which permit movement of guide wire and balloon inflation. The distal portion of the shaft has hydrophilic coating applied on it, in order to facilitate catheter advancing through the vascular district and the vessel stenosis.The compliance chart on the inner and outer label indicates how the balloon diameter increases with increasing pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. Guide wire compatibility: 0.035”. The Mozec PTA Balloon Dilatation Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010401020101 | PTCA BALLOON DILATION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 261394-2018-CE-IND-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).