K260304
- 510(k) number
- K260304
- Device name
- WAVE PTA Balloon Catheter
- Applicant
- WAVE Medical AG CH
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2026-05-20
- Date received
- 2026-01-30
- 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: K260304.pdf
Official FDA record: K260304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.