K241478
- 510(k) number
- K241478
- Device name
- Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- Applicant
- Brosmed Medical Co., Ltd. CN
- Product code
- PNO — Catheter, Percutaneous, Cutting/Scoring
- Decision date
- 2024-10-22
- Date received
- 2024-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K241478.pdf
Official FDA record: K241478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.