Clearance Summary
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter received FDA 510(k) clearance under submission number K262201, sponsored by Shockwave Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-07-27.
- Submission: K262201
- Applicant / Sponsor: Shockwave Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2026-07-27
Classification & Regulation
This clearance is catalogued under FDA product code PPN and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.