K262201
- 510(k) number
- K262201
- 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
- 2026-07-27
- Date received
- 2026-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K262201.pdf
Official FDA record: K262201
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.