Aperta NSE™ PTA Balloon Dilatation Catheter AW18-09050040
GUDID 04543660025755
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 = 5.0mm, Length = 40mm, 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.
GOODMAN CO.,LTD.
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 04543660025755 |
| NIH Device Record Key | 0676fa93-e64d-4273-8bb8-cf187ef681a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aperta NSE™ PTA Balloon Dilatation Catheter |
| Version Model Number | AW18-09050040 |
| Catalog Number | AW18-09050040 |
| Company DUNS | 690965116 |
| Company Name | GOODMAN CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com | |
| Phone | 800-596-3104 |
| customerservice@infraredx.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543660025755 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232013
FDA Product Code
| PNO | Catheter, Percutaneous, Cutting/Scoring |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-13 |
| Device Publish Date | 2024-05-03 |
On-Brand Devices [Aperta NSE™ PTA Balloon Dilatation Catheter]
| 04543660025830 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025823 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025816 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025809 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025793 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025786 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025779 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025762 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025755 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025748 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025731 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025724 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025717 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025700 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025694 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025632 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025625 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025618 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025601 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
| 04543660025595 | The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce sl |
Trademark Results [Aperta NSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APERTA NSE 97150767 not registered Live/Pending |
Goodman Co., Ltd. 2021-12-01 |
 APERTA NSE 79318347 not registered Live/Pending |
Goodman Co., Ltd. 2021-05-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.