Data / Medical devices / Japan / NIPRO VASCULAR CORPORATION Fujigaoka Building
NIPRO VASCULAR CORPORATION Fujigaoka Building: FDA-registered device maker in Nagoya Aichi, Japan, 2 510(k) clearances
NIPRO VASCULAR CORPORATION Fujigaoka Building is registered with the FDA (registration 1000533027) in Nagoya Aichi, Japan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 22, 2025. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1000533027
- Address
- 108 Fujigaoka Meito-ku, Nagoya Aichi, Japan, 465-0032
- Owner or operator
- NIPRO VASCULAR CORPORATION (10061300)
- Roles
- Complaint file establishment
- First device listed
- October 7, 2019
- Registered through
- 2027
- Brand names listed
- Aperta NSE PTA Balloon Dilatation Catheter, GM-30 Inflation Device, OKAYII Y-Connector Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 22, 2025 | K243944 | Aperta NSE PTA Balloon Dilatation Catheter | PNO | Substantially Equivalent | Goodman Co., Ltd. | accessdata.fda.gov |
| March 28, 2024 | K232013 | 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) | PNO | Substantially Equivalent | Goodman Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous, Cutting/Scoring
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Updated April 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.