K232207
- 510(k) number
- K232207
- Device name
- D·Kutting PTA Scoring Balloon Dilatation Catheter
- Applicant
- Dk Medical Technology Co., Ltd. CN
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2024-03-07
- Date received
- 2023-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K232207.pdf
Official FDA record: K232207
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.