DeviceClearance

K250225

Substantially Equivalent

Bolt Intravascular Lithotripsy (IVL) System

Applicant
Bolt Medical, Inc.
Product code
PPN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, 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.