Aperta NSE™ PTA Balloon Dilatation Catheter
Aperta NSE PTA is an over-the-wire balloon catheter for dilating narrowed peripheral vessels and obstructed arteriovenous dialysis fistulae. Protruding polymer elements run parallel to the…
Aperta NSE PTA is an over-the-wire balloon catheter for dilating narrowed peripheral vessels and obstructed arteriovenous dialysis fistulae. Protruding polymer elements run parallel to the balloon to assist expansion of lesions that are difficult to dilate with a conventional balloon.
The catheter is positioned over a guidewire, and the balloon is inflated at the lesion. Its role includes treatment of in-stent restenosis in the peripheral vasculature, within its specified vascular indications.
Listed Item
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 145cm, Diameter = 4.0mm, Length = 100mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
Balloon and Marker Configurations
The range includes longer balloon models with 100 and 150 mm balloon lengths. These longer configurations use two radiopaque markers at the distal balloon end and one at the proximal end. The device is intended for peripheral use and excludes coronary and neurovascular vessels, including carotid arteries.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Goodman Co., Ltd., United States |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K243944 |
| Record published | 2024-05-03 |
| Record revised | 2026-04-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry; Special storage condition: Do not use if package is damaged |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AW18-14560040 | In distribution | |
| AA18-05070040 | In distribution | |
| AW18-05080040 | In distribution | |
| AA18-05040040 | In distribution | |
| AW18-14580040 | In distribution | |
| AW18-09070040 | In distribution | |
| AW18-05060040 | In distribution | |
| LW18-09050150 | In distribution | |
| AW18-05070040 | In distribution | |
| LW18-09040150 | In distribution | |
| LW18-14540100 | In distribution | |
| LA18-05050100 | In distribution | |
| AW18-09040040 | In distribution | |
| LA18-05040100 | In distribution | |
| AW18-09060040 | In distribution | |
| AW18-09080040 | In distribution | |
| AW18-14550040 | In distribution | |
| LW18-14550100 | In distribution | |
| AA18-05080040 | In distribution | |
| LW18-09040100 | In distribution | |
| LW18-14560100 | In distribution | |
| LA18-05050150 | In distribution | |
| AW18-05040040 | In distribution | |
| LW18-14550150 | In distribution | |
| LA18-05060150 | In distribution | |
| LA18-05060100 | In distribution | |
| LW18-09060150 | In distribution | |
| AW18-14570040 | In distribution | |
| LW18-14560150 | In distribution | |
| LW18-09050100 | In distribution | |
| AA18-05050040 | In distribution | |
| LW18-14540150 | In distribution | |
| AA18-05060040 | In distribution | |
| AW18-05050040 | In distribution | |
| LA18-05040150 | In distribution | |
| AW18-14540040 | In distribution | |
| AW18-09050040 | In distribution | |
| LW18-09060100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 120 |
| VascuTrak® | Bard Peripheral Vascular, Inc. | 109 |
| Ultrascore | Bard Peripheral Vascular, Inc. | 103 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| AngioSculpt® | Spectranetics Corp. | 51 |
| AngioSculpt OTW PTA Scoring Balloon Catheter | The Spectranetics Corp. | 25 |
| Serranator | Cagent Vascular | 18 |
| AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating | The Spectranetics Corp. | 13 |
| Advance Enforcer | Cook Incorporated | 12 |
| 2cm Peripheral Cutting Balloon® | Boston Scientific Corporation | 12 |
| Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 11 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243944 | 2025-04-22 |
| K232013 | 2024-03-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.