510(k) clearance

SEISMIQ™ Intravascular Lithotripsy System

FDA 510(k) source

510(k) number

K260246

Applicant

Bolt Medical, Inc.

Decision date

Aug 24, 2026

Date received

Jan 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

PPN

Device type

Percutaneous Catheter, Ultrasound

Device class

Class II

Regulation

21 CFR 870.1250

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Carlsbad, CA, US