K232013
- 510(k) number
- K232013
- Device name
- 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)
- Applicant
- Goodman Co., Ltd. JP
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2024-03-28
- Date received
- 2023-07-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232013.pdf
Official FDA record: K232013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.