Angioplasty balloons
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
by OrbusNeich Medical (ShenZhen) Co., Ltd.
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
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Where to buy JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
We do not have contact details for OrbusNeich Medical (ShenZhen) Co., Ltd. yet. Send a request and we will route it to the right person for your country.
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 5915-015-12 | — | Not stated | Available |
| 5915-015-22 | — | Not stated | Available |
| 5915-015-32 | — | Not stated | Available |
| 5915-020-12 | — | Not stated | Available |
| 5915-020-22 | — | Not stated | Available |
| 5915-020-32 | — | Not stated | Available |
| 5915-040-12 | — | Not stated | Available |
| 5915-040-22 | — | Not stated | Available |
| 5915-040-32 | — | Not stated | Available |
| 5915-060-12 | — | Not stated | Available |
| 5915-060-22 | — | Not stated | Available |
| 5915-060-32 | — | Not stated | Available |
| 5915-080-12 | — | Not stated | Available |
| 5915-080-22 | — | Not stated | Available |
| 5915-080-32 | — | Not stated | Available |
| 5915-100-12 | — | Not stated | Available |
| 5915-100-22 | — | Not stated | Available |
| 5915-100-32 | — | Not stated | Available |
| 5915-120-12 | — | Not stated | Available |
| 5915-120-22 | — | Not stated | Available |
| 5915-120-32 | — | Not stated | Available |
| 5915-150-12 | — | Not stated | Available |
| 5915-150-22 | — | Not stated | Available |
| 5915-150-32 | — | Not stated | Available |
| 5915-180-12 | — | Not stated | Available |
| 5915-180-22 | — | Not stated | Available |
| 5915-180-32 | — | Not stated | Available |
| 5915-240-12 | — | Not stated | Available |
| 5915-240-22 | — | Not stated | Available |
| 5915-240-32 | — | Not stated | Available |
| 5915-300-12 | — | Not stated | Available |
| 5915-300-22 | — | Not stated | Available |
| 5915-300-32 | — | Not stated | Available |
| 5920-015-12 | — | Not stated | Available |
| 5920-015-22 | — | Not stated | Available |
| 5920-015-32 | — | Not stated | Available |
| 5920-020-12 | — | Not stated | Available |
| 5920-020-22 | — | Not stated | Available |
| 5920-020-32 | — | Not stated | Available |
| 5920-040-12 | — | Not stated | Available |
| 5920-040-22 | — | Not stated | Available |
| 5920-040-32 | — | Not stated | Available |
| 5920-060-12 | — | Not stated | Available |
| 5920-060-22 | — | Not stated | Available |
| 5920-060-32 | — | Not stated | Available |
| 5920-080-12 | — | Not stated | Available |
| 5920-080-22 | — | Not stated | Available |
| 5920-080-32 | — | Not stated | Available |
| 5920-100-12 | — | Not stated | Available |
| 5920-100-22 | — | Not stated | Available |
| 5920-100-32 | — | Not stated | Available |
| 5920-120-12 | — | Not stated | Available |
| 5920-120-22 | — | Not stated | Available |
| 5920-120-32 | — | Not stated | Available |
| 5920-150-12 | — | Not stated | Available |
| 5920-150-22 | — | Not stated | Available |
| 5920-150-32 | — | Not stated | Available |
| 5920-180-12 | — | Not stated | Available |
| 5920-180-22 | — | Not stated | Available |
| 5920-180-32 | — | Not stated | Available |
| 5920-240-12 | — | Not stated | Available |
| 5920-240-22 | — | Not stated | Available |
| 5920-240-32 | — | Not stated | Available |
| 5920-300-12 | — | Not stated | Available |
| 5920-300-22 | — | Not stated | Available |
| 5920-300-32 | — | Not stated | Available |
| 5925-015-12 | — | Not stated | Available |
| 5925-015-22 | — | Not stated | Available |
| 5925-015-32 | — | Not stated | Available |
| 5925-020-12 | — | Not stated | Available |
| 5925-020-22 | — | Not stated | Available |
| 5925-020-32 | — | Not stated | Available |
| 5925-040-12 | — | Not stated | Available |
| 5925-040-22 | — | Not stated | Available |
| 5925-040-32 | — | Not stated | Available |
| 5925-060-12 | — | Not stated | Available |
| 5925-060-22 | — | Not stated | Available |
| 5925-060-32 | — | Not stated | Available |
| 5925-080-12 | — | Not stated | Available |
| 5925-080-22 | — | Not stated | Available |
| 5925-080-32 | — | Not stated | Available |
| 5925-100-12 | — | Not stated | Available |
| 5925-100-22 | — | Not stated | Available |
| 5925-100-32 | — | Not stated | Available |
| 5925-120-12 | — | Not stated | Available |
| 5925-120-22 | — | Not stated | Available |
| 5925-120-32 | — | Not stated | Available |
| 5925-150-12 | — | Not stated | Available |
| 5925-150-22 | — | Not stated | Available |
| 5925-150-32 | — | Not stated | Available |
| 5925-180-12 | — | Not stated | Available |
| 5925-180-22 | — | Not stated | Available |
| 5925-180-32 | — | Not stated | Available |
| 5925-240-12 | — | Not stated | Available |
| 5925-240-22 | — | Not stated | Available |
| 5925-240-32 | — | Not stated | Available |
| 5925-300-12 | — | Not stated | Available |
| 5925-300-22 | — | Not stated | Available |
| 5925-300-32 | — | Not stated | Available |
| 5930-015-12 | — | Not stated | Available |
| 5930-015-22 | — | Not stated | Available |
| 5930-015-32 | — | Not stated | Available |
| 5930-020-12 | — | Not stated | Available |
| 5930-020-22 | — | Not stated | Available |
| 5930-020-32 | — | Not stated | Available |
| 5930-040-12 | — | Not stated | Available |
| 5930-040-22 | — | Not stated | Available |
| 5930-040-32 | — | Not stated | Available |
| 5930-060-12 | — | Not stated | Available |
| 5930-060-22 | — | Not stated | Available |
| 5930-060-32 | — | Not stated | Available |
| 5930-080-12 | — | Not stated | Available |
| 5930-080-22 | — | Not stated | Available |
| 5930-080-32 | — | Not stated | Available |
| 5930-100-12 | — | Not stated | Available |
| 5930-100-22 | — | Not stated | Available |
| 5930-100-32 | — | Not stated | Available |
| 5930-120-12 | — | Not stated | Available |
| 5930-120-22 | — | Not stated | Available |
| 5930-120-32 | — | Not stated | Available |
| 5930-150-12 | — | Not stated | Available |
| 5930-150-22 | — | Not stated | Available |
| 5930-150-32 | — | Not stated | Available |
| 5930-180-12 | — | Not stated | Available |
| 5930-180-22 | — | Not stated | Available |
| 5930-180-32 | — | Not stated | Available |
| 5930-240-12 | — | Not stated | Available |
| 5930-240-22 | — | Not stated | Available |
| 5930-240-32 | — | Not stated | Available |
| 5930-300-12 | — | Not stated | Available |
| 5930-300-22 | — | Not stated | Available |
| 5930-300-32 | — | Not stated | Available |
| 5935-015-12 | — | Not stated | Available |
| 5935-015-22 | — | Not stated | Available |
| 5935-015-32 | — | Not stated | Available |
| 5935-020-12 | — | Not stated | Available |
| 5935-020-22 | — | Not stated | Available |
| 5935-020-32 | — | Not stated | Available |
| 5935-040-12 | — | Not stated | Available |
| 5935-040-22 | — | Not stated | Available |
| 5935-040-32 | — | Not stated | Available |
| 5935-060-12 | — | Not stated | Available |
| 5935-060-22 | — | Not stated | Available |
| 5935-060-32 | — | Not stated | Available |
| 5935-080-12 | — | Not stated | Available |
| 5935-080-22 | — | Not stated | Available |
| 5935-080-32 | — | Not stated | Available |
| 5935-100-12 | — | Not stated | Available |
| 5935-100-22 | — | Not stated | Available |
| 5935-100-32 | — | Not stated | Available |
| 5935-120-12 | — | Not stated | Available |
| 5935-120-22 | — | Not stated | Available |
| 5935-120-32 | — | Not stated | Available |
| 5935-150-12 | — | Not stated | Available |
| 5935-150-22 | — | Not stated | Available |
| 5935-150-32 | — | Not stated | Available |
| 5935-180-12 | — | Not stated | Available |
| 5935-180-22 | — | Not stated | Available |
| 5935-180-32 | — | Not stated | Available |
| 5935-240-12 | — | Not stated | Available |
| 5935-240-22 | — | Not stated | Available |
| 5935-240-32 | — | Not stated | Available |
| 5935-300-12 | — | Not stated | Available |
| 5935-300-22 | — | Not stated | Available |
| 5935-300-32 | — | Not stated | Available |
| 5940-015-12 | — | Not stated | Available |
| 5940-015-22 | — | Not stated | Available |
| 5940-015-32 | — | Not stated | Available |
| 5940-020-12 | — | Not stated | Available |
| 5940-020-22 | — | Not stated | Available |
| 5940-020-32 | — | Not stated | Available |
| 5940-040-12 | — | Not stated | Available |
| 5940-040-22 | — | Not stated | Available |
| 5940-040-32 | — | Not stated | Available |
| 5940-060-12 | — | Not stated | Available |
| 5940-060-22 | — | Not stated | Available |
| 5940-060-32 | — | Not stated | Available |
| 5940-080-12 | — | Not stated | Available |
| 5940-080-22 | — | Not stated | Available |
| 5940-080-32 | — | Not stated | Available |
| 5940-100-12 | — | Not stated | Available |
| 5940-100-22 | — | Not stated | Available |
| 5940-100-32 | — | Not stated | Available |
| 5940-120-12 | — | Not stated | Available |
| 5940-120-22 | — | Not stated | Available |
| 5940-120-32 | — | Not stated | Available |
| 5940-150-12 | — | Not stated | Available |
| 5940-150-22 | — | Not stated | Available |
| 5940-150-32 | — | Not stated | Available |
| 5940-180-12 | — | Not stated | Available |
| 5940-180-22 | — | Not stated | Available |
| 5940-180-32 | — | Not stated | Available |
| 5940-240-12 | — | Not stated | Available |
| 5940-240-22 | — | Not stated | Available |
| 5940-240-32 | — | Not stated | Available |
| 5940-300-12 | — | Not stated | Available |
| 5940-300-22 | — | Not stated | Available |
| 5940-300-32 | — | Not stated | Available |
| 5945-015-12 | — | Not stated | Available |
| 5945-015-22 | — | Not stated | Available |
| 5945-015-32 | — | Not stated | Available |
| 5945-020-12 | — | Not stated | Available |
| 5945-020-22 | — | Not stated | Available |
| 5945-020-32 | — | Not stated | Available |
| 5945-040-12 | — | Not stated | Available |
| 5945-040-22 | — | Not stated | Available |
| 5945-040-32 | — | Not stated | Available |
| 5945-060-12 | — | Not stated | Available |
| 5945-060-22 | — | Not stated | Available |
| 5945-060-32 | — | Not stated | Available |
| 5945-080-12 | — | Not stated | Available |
| 5945-080-22 | — | Not stated | Available |
| 5945-080-32 | — | Not stated | Available |
| 5945-100-12 | — | Not stated | Available |
| 5945-100-22 | — | Not stated | Available |
| 5945-100-32 | — | Not stated | Available |
| 5945-120-12 | — | Not stated | Available |
| 5945-120-22 | — | Not stated | Available |
| 5945-120-32 | — | Not stated | Available |
| 5945-150-12 | — | Not stated | Available |
| 5945-150-22 | — | Not stated | Available |
| 5945-150-32 | — | Not stated | Available |
| 5945-180-12 | — | Not stated | Available |
| 5945-180-22 | — | Not stated | Available |
| 5945-180-32 | — | Not stated | Available |
| 5945-240-12 | — | Not stated | Available |
| 5945-240-22 | — | Not stated | Available |
| 5945-240-32 | — | Not stated | Available |
| 5945-300-12 | — | Not stated | Available |
| 5945-300-22 | — | Not stated | Available |
| 5945-300-32 | — | Not stated | Available |
| 5950-015-12 | — | Not stated | Available |
| 5950-015-22 | — | Not stated | Available |
| 5950-015-32 | — | Not stated | Available |
| 5950-020-12 | — | Not stated | Available |
| 5950-020-22 | — | Not stated | Available |
| 5950-020-32 | — | Not stated | Available |
| 5950-040-12 | — | Not stated | Available |
| 5950-040-22 | — | Not stated | Available |
| 5950-040-32 | — | Not stated | Available |
| 5950-060-12 | — | Not stated | Available |
| 5950-060-22 | — | Not stated | Available |
| 5950-060-32 | — | Not stated | Available |
| 5950-080-12 | — | Not stated | Available |
| 5950-080-22 | — | Not stated | Available |
| 5950-080-32 | — | Not stated | Available |
| 5950-100-12 | — | Not stated | Available |
| 5950-100-22 | — | Not stated | Available |
| 5950-100-32 | — | Not stated | Available |
| 5950-120-12 | — | Not stated | Available |
FDA clearances
- 510(k) K241025 June 2024
Procedures that use angioplasty balloons
Frequently asked questions
What is JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW used for?
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Who makes JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW?
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW is made by OrbusNeich Medical (ShenZhen) Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW come in?
The FDA device database does not list sizes for JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW. Check the instructions for use or ask a OrbusNeich Medical (ShenZhen) Co., Ltd. representative.
Is JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW MRI safe?
The FDA device database entry for JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW does not state its MRI safety status. Check the labeling before MRI.
Is JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW FDA cleared?
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW is covered by FDA submission K241025.
How do I contact a OrbusNeich Medical (ShenZhen) Co., Ltd. sales representative?
OrbusNeich Medical (ShenZhen) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the OrbusNeich Medical (ShenZhen) Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.