K240225
- 510(k) number
- K240225
- Device name
- Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- Applicant
- Shockwave Medical, Inc. CA · US
- Product code
- PPN — Percutaneous Catheter, Ultrasound
- Decision date
- 2024-03-22
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240225.pdf
Official FDA record: K240225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.