K250219
- 510(k) number
- K250219
- Device name
- Dorado PTA Balloon Dilatation Catheter
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-17
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250219.pdf
Official FDA record: K250219
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.