Jade PTA
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Basic Information
- Primary DI
- 08717853299261
- Basic UDI-DI Code
- B-08717853299261
- Reference
- 560-015-41
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- OrbusNeich Medical, B.V.
Additional Description
The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter is a rapid exchange balloon catheter for peripheral indications, not for coronary or neuro-vasculature. Balloon Diameters range from 1.5 mm to 6.0 mm and catheter length is 150 cm. The balloon material is made of a minimally compliant material. The balloons of 1.5-4.0 mm have a rated burst pressure of 22 atm, 4.5-5.0 mm with a rated burst pressure of 20 atm and 5.5-6.0 mm with a rated burst pressure of 18 atm.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010402020101 | PTA BALLOON DILATATION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 619995 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).