Aperta NSE™ PTA Balloon Dilatation Catheter
Basic Information
- Brand Name
- Aperta NSE™ PTA Balloon Dilatation Catheter
- Primary DI
- 04543660025762
- Version / Model
- AW18-09060040
- Catalog Number
- AW18-09060040
- Company Name
- GOODMAN CO.,LTD.
- Labeler DUNS
- 690965116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-03
- Public Version
- 2
- Public Version Date
- 2026-04-02
- Public Version Status
- Update
- Public Device Record Key
- d85a60d9-c3f5-4d1b-a8f6-84d82785e0ec
Device Description
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 = 90cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17184 | Peripheral angioplasty balloon catheter, basic | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04543660025762 | GS1 |
Customer Contacts
- Phone
- 800-596-3104
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged