Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter— 510(k) K203365

Substantially Equivalent

Shockwave Medical, Inc.

FDA 510(k) clearance K203365 for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter, Substantially Equivalent on 2021-04-22. Applicant: Shockwave Medical, Inc..

Clearance details

Applicant: Shockwave Medical, Inc.
Product code: Code PPN
Advisory panel: Cardiovascular
Date received: 2020-11-16
Decision date: 2021-04-22
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.