Angioplasty balloons
Sapphire II Pro
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.
Contact OrbusNeich Medical (ShenZhen) Co., Ltd. ↗ Where to buy Compare similar devices
Find similar PTA balloons
Where to buy Sapphire II Pro
Contact OrbusNeich Medical (ShenZhen) Co., Ltd. directly; they can quote, ship, or point you to the distributor for your country.
From orbusneich.com, checked October 2026.
No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.
Sapphire II Pro 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 |
|---|---|---|---|
| 210-053-5UU | Outer Diameter 1.0 mm; Length 5 mm | Not stated | Available |
| 210-083-5UU | Length 8 mm; Outer Diameter 1.0 mm | Not stated | Available |
| 210-103-5UU | Outer Diameter 1.0 mm; Length 10 mm | Not stated | Available |
| 210-153-5UU | Length 15 mm; Outer Diameter 1.0 mm | Not stated | Available |
| 212-053-5UU | Outer Diameter 1.25 mm; Length 5 mm | Not stated | Available |
| 212-083-5UU | Length 8 mm; Outer Diameter 1.25 mm | Not stated | Available |
| 212-103-5UU | Outer Diameter 1.25 mm; Length 10 mm | Not stated | Available |
| 212-153-5UU | Length 15 mm; Outer Diameter 1.25 mm | Not stated | Available |
| 217-153-5UU | — | Not stated | Available |
FDA clearances
- 510(k) K180921 June 2018
Procedures that use angioplasty balloons
Frequently asked questions
What is Sapphire II Pro 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 Sapphire II Pro?
Sapphire II Pro is made by OrbusNeich Medical (ShenZhen) Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Sapphire II Pro come in?
Sizes listed for Sapphire II Pro: Length: 5–15 mm; Outer Diameter: 1–1.25 mm. Confirm availability with the manufacturer's instructions for use.
Is Sapphire II Pro MRI safe?
The FDA device database entry for Sapphire II Pro does not state its MRI safety status. Check the labeling before MRI.
Is Sapphire II Pro FDA cleared?
Sapphire II Pro is covered by FDA submission K180921.
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.