K243944
- 510(k) number
- K243944
- Device name
- Aperta NSE PTA Balloon Dilatation Catheter
- Applicant
- Goodman Co., Ltd. JP
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2025-04-22
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243944.pdf
Official FDA record: K243944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.