Angioplasty balloons
Scoreflex PTA Scoring Balloon Catheter
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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Scoreflex PTA Scoring Balloon Catheter 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 |
|---|---|---|---|
| AL620-154CU | Balloon Diameter 2.0 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL620-154NU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| AL620-204CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| AL620-204NU | Balloon Diameter 2.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL620-404CU | Balloon Diameter 2.0 mm; Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL620-404NU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| AL625-154CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| AL625-154NU | Balloon Diameter 2.5 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL625-204CU | Balloon Diameter 2.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL625-204NU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| AL625-404CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| AL625-404NU | Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm; Balloon Diameter 2.5 mm | Not stated | Available |
| AL630-154CU | Balloon Diameter 3.0 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL630-154NU | Balloon Diameter 3.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm | Not stated | Available |
| AL630-204CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| AL630-204NU | Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm; Balloon Diameter 3.0 mm | Not stated | Available |
| AL630-404CU | Balloon Diameter 3.0 mm; Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL630-404NU | Balloon Diameter 3.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm | Not stated | Available |
| AL635-154CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm; Balloon Diameter 3.5 mm | Not stated | Available |
| AL635-154NU | Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| AL635-204CU | Balloon Diameter 3.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL635-204NU | Balloon Diameter 3.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm | Not stated | Available |
| AL635-404CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 3.5 mm | Not stated | Available |
| AL635-404NU | Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| AL640-154CU | Balloon Diameter 4.0 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL640-154NU | Balloon Diameter 4.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm | Not stated | Available |
| AL640-204CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 4.0 mm | Not stated | Available |
| AL640-204NU | Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| AL640-404CU | Balloon Diameter 4.0 mm; Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL640-404NU | Balloon Diameter 4.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm | Not stated | Available |
| AL645-154CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm; Balloon Diameter 4.5 mm | Not stated | Available |
| AL645-204CU | Balloon Diameter 4.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL645-404CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 4.5 mm | Not stated | Available |
| AL650-154CU | Balloon Diameter 5.0 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL650-204CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 5.0 mm | Not stated | Available |
| AL650-404CU | Balloon Diameter 5.0 mm; Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL655-154CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 15 mm; Balloon Diameter 5.5 mm | Not stated | Available |
| AL655-204CU | Balloon Diameter 5.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL655-404CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 5.5 mm | Not stated | Available |
| AL660-154CU | Balloon Diameter 6.0 mm; Balloon Length 15 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AL660-204CU | Catheter Length 150 cm; Guidewire Diameter 0.014 in; Balloon Length 20 mm; Balloon Diameter 6.0 mm | Not stated | Available |
| AL660-404CU | Balloon Diameter 6.0 mm; Balloon Length 40 mm; Guidewire Diameter 0.014 in; Catheter Length 150 cm | Not stated | Available |
| AM620-204CU | Balloon Diameter 2.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM620-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 2.0 mm | Not stated | Available |
| AM625-204CU | Balloon Diameter 2.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM625-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 2.5 mm | Not stated | Available |
| AM630-204CU | Balloon Diameter 3.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM630-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 3.0 mm | Not stated | Available |
| AM635-204CU | Balloon Diameter 3.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM635-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 3.5 mm | Not stated | Available |
| AM640-204CU | Balloon Diameter 4.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM640-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 4.0 mm | Not stated | Available |
| AM645-204CU | Balloon Diameter 4.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM645-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 4.5 mm | Not stated | Available |
| AM650-204CU | Balloon Diameter 5.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM650-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 5.0 mm | Not stated | Available |
| AM655-204CU | Balloon Diameter 5.5 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM655-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 5.5 mm | Not stated | Available |
| AM660-204CU | Balloon Diameter 6.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 90 cm | Not stated | Available |
| AM660-404CU | Catheter Length 90 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 6.0 mm | Not stated | Available |
| AS640-204CU | Catheter Length 40 cm; Balloon Length 20 mm; Balloon Diameter 4.0 mm; Guidewire Diameter 0.014 in | Not stated | Available |
| AS640-404CU | Catheter Length 40 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 4.0 mm | Not stated | Available |
| AS650-204CU | Balloon Diameter 5.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 40 cm | Not stated | Available |
| AS650-404CU | Catheter Length 40 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 5.0 mm | Not stated | Available |
| AS660-204CU | Balloon Diameter 6.0 mm; Balloon Length 20 mm; Guidewire Diameter 0.014 in; Catheter Length 40 cm | Not stated | Available |
| AS660-404CU | Catheter Length 40 cm; Guidewire Diameter 0.014 in; Balloon Length 40 mm; Balloon Diameter 6.0 mm | Not stated | Available |
| BL620-154CU | Balloon Length 15 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 2.0 mm | Not stated | Available |
| BL620-204CU | Balloon Length 40 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 2.0 mm | Not stated | Available |
| BL620-204CU | Balloon Diameter 2.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 20 mm | Not stated | Available |
| BL625-154CU | Balloon Diameter 2.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 15 mm | Not stated | Available |
| BL625-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 2.5 mm | Not stated | Available |
| BL625-404CU | Balloon Diameter 2.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BL630-154CU | Balloon Length 15 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 3.0 mm | Not stated | Available |
| BL630-204CU | Balloon Diameter 3.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 20 mm | Not stated | Available |
| BL630-404CU | Balloon Length 40 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 3.0 mm | Not stated | Available |
| BL635-154CU | Balloon Diameter 3.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 15 mm | Not stated | Available |
| BL635-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| BL635-404CU | Balloon Diameter 3.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BL640-154CU | Balloon Length 15 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| BL640-204CU | Balloon Diameter 4.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 20 mm | Not stated | Available |
| BL640-404CU | Balloon Length 40 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| BL645-154CU | Balloon Diameter 4.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 15 mm | Not stated | Available |
| BL645-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 4.5 mm | Not stated | Available |
| BL645-404CU | Balloon Diameter 4.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BL650-154CU | Balloon Length 15 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| BL650-204CU | Balloon Diameter 5.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 20 mm | Not stated | Available |
| BL650-404CU | Balloon Length 40 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| BL655-154CU | Balloon Diameter 5.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 15 mm | Not stated | Available |
| BL655-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 5.5 mm | Not stated | Available |
| BL655-404CU | Balloon Diameter 5.5 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BL660-154CU | Balloon Length 15 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 6.0 mm | Not stated | Available |
| BL660-204CU | Balloon Diameter 6.0 mm; Catheter Length 150 cm; Guidewire Diameter 0.018 in; Balloon Length 20 mm | Not stated | Available |
| BL660-404CU | Balloon Length 40 mm; Guidewire Diameter 0.018 in; Catheter Length 150 cm; Balloon Diameter 6.0 mm | Not stated | Available |
| BM620-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 2.0 mm | Not stated | Available |
| BM620-404CU | Balloon Diameter 2.0 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM625-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 2.5 mm | Not stated | Available |
| BM625-404CU | Balloon Diameter 2.5 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM630-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 3.0 mm | Not stated | Available |
| BM630-404CU | Balloon Diameter 3.0 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM635-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 3.5 mm | Not stated | Available |
| BM635-404CU | Balloon Diameter 3.5 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM640-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| BM640-404CU | Balloon Diameter 4.0 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM645-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 4.5 mm | Not stated | Available |
| BM645-404CU | Balloon Diameter 4.5 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM650-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| BM650-404CU | Balloon Diameter 5.0 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM655-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 5.5 mm | Not stated | Available |
| BM655-404CU | Balloon Diameter 5.5 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BM660-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 90 cm; Balloon Diameter 6.0 mm | Not stated | Available |
| BM660-404CU | Balloon Diameter 6.0 mm; Catheter Length 90 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BS640-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 40 cm; Balloon Diameter 4.0 mm | Not stated | Available |
| BS640-404CU | Balloon Diameter 4.0 mm; Catheter Length 40 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BS650-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 40 cm; Balloon Diameter 5.0 mm | Not stated | Available |
| BS650-404CU | Balloon Diameter 5.0 mm; Catheter Length 40 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
| BS660-204CU | Balloon Length 20 mm; Guidewire Diameter 0.018 in; Catheter Length 40 cm; Balloon Diameter 6.0 mm | Not stated | Available |
| BS660-404CU | Balloon Diameter 6.0 mm; Catheter Length 40 cm; Guidewire Diameter 0.018 in; Balloon Length 40 mm | Not stated | Available |
FDA clearances
- 510(k) K182713 June 2019
Procedures that use angioplasty balloons
Frequently asked questions
What is Scoreflex PTA Scoring Balloon Catheter 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 Scoreflex PTA Scoring Balloon Catheter?
Scoreflex PTA Scoring Balloon Catheter is made by OrbusNeich Medical (ShenZhen) Co., Ltd.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Scoreflex PTA Scoring Balloon Catheter come in?
Sizes listed for Scoreflex PTA Scoring Balloon Catheter: Balloon Length: 15–40 mm; Guidewire Diameter: 0.01–0.02 in; Catheter Length: 40–150 cm. Confirm availability with the manufacturer's instructions for use.
Is Scoreflex PTA Scoring Balloon Catheter MRI safe?
The FDA device database entry for Scoreflex PTA Scoring Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Scoreflex PTA Scoring Balloon Catheter FDA cleared?
Scoreflex PTA Scoring Balloon Catheter is covered by FDA submission K182713.
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.