Aperta NSE™ PTA Balloon Dilatation Catheter
- Primary DI
- 04543660025618
- Brand
- Aperta NSE™ PTA Balloon Dilatation Catheter
- Company
- GOODMAN CO.,LTD.
- Model
- AA18-05060040
- Catalog number
- AA18-05060040
- 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 = 50cm, 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.
- Published
- 2024-08-05
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K232013 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K232013 | 000 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | Goodman Co., Ltd. | 2024-03-28 | PNO |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04543660025618 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04543660025618 | 04543660025618 | 4543660025618 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not use if package is damaged |
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 800-596-3104 | customerservice@infraredx.com |
| 800-596-3104 | regulatoryNVIA@nipromed.com |
Regulatory Flags#
- DUNS number
- 690965116
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04543660026363 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09040100 | LW18-09040100 | 2025-05-12 |
| 04543660026370 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09040150 | LW18-09040150 | 2025-05-12 |
| 04543660026387 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09050100 | LW18-09050100 | 2025-05-12 |
| 04543660026394 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09050150 | LW18-09050150 | 2025-05-12 |
| 04543660026400 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09060100 | LW18-09060100 | 2025-05-12 |
| 04543660026417 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-09060150 | LW18-09060150 | 2025-05-12 |
| 04543660026424 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14540100 | LW18-14540100 | 2025-05-12 |
| 04543660026431 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14540150 | LW18-14540150 | 2025-05-12 |
| 04543660026448 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14550100 | LW18-14550100 | 2025-05-12 |
| 04543660026455 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14550150 | LW18-14550150 | 2025-05-12 |
| 04543660026462 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14560100 | LW18-14560100 | 2025-05-12 |
| 04543660026479 | Aperta NSE™ PTA Balloon Dilatation Catheter | LW18-14560150 | LW18-14560150 | 2025-05-12 |
| 04543660026486 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05040100 | LA18-05040100 | 2025-05-12 |
| 04543660026493 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05040150 | LA18-05040150 | 2025-05-12 |
| 04543660026509 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05050100 | LA18-05050100 | 2025-05-12 |
| 04543660026516 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05050150 | LA18-05050150 | 2025-05-12 |
| 04543660026523 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05060100 | LA18-05060100 | 2025-05-12 |
| 04543660026530 | Aperta NSE™ PTA Balloon Dilatation Catheter | LA18-05060150 | LA18-05060150 | 2025-05-12 |
| 04543660025595 | Aperta NSE™ PTA Balloon Dilatation Catheter | AA18-05040040 | AA18-05040040 | 2024-08-05 |
| 04543660025601 | Aperta NSE™ PTA Balloon Dilatation Catheter | AA18-05050040 | AA18-05050040 | 2024-08-05 |
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|---|---|---|---|---|
| 06923533801057 | Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | 2026-05-15 |
| B090XC2201450 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
| B090XC2201451 | XO Constrain | ZIEN MEDICAL TECHNOLOGIES, INC. | PNO | 2026-02-03 |
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