Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter— 510(k) K240225

Substantially Equivalent

Shockwave Medical, Inc.

FDA 510(k) clearance K240225 for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter, Substantially Equivalent on 2024-03-22. Applicant: Shockwave Medical, Inc..

Clearance details

Applicant: Shockwave Medical, Inc.
Product code: Code PPN
Advisory panel: Cardiovascular
Date received: 2024-01-26
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PPN

product code PPN

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.