DeviceClearance

K203365

Substantially Equivalent

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter

Applicant
Shockwave Medical, Inc.
Product code
PPN
Advisory panel
Cardiovascular
Date received
Decision date
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, through . 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.