SEISMIQ Intravascular Lithotripsy System— 510(k) K260246
Substantially EquivalentBolt Medical, Inc.
FDA 510(k) clearance K260246 for SEISMIQ Intravascular Lithotripsy System, Substantially Equivalent on 2026-08-24. Applicant: Bolt Medical, Inc.. Device class: 2.
Summary
Bolt Medical's SEISMIQ Intravascular Lithotripsy System is filed under product code PPN, percutaneous ultrasound catheters. The record doesn't describe the system beyond its name and that code.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Bolt Medical filed from Carlsbad, California. The decision came 209 calendar days after FDA received it (January 27 to August 24, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Bolt Medical, Inc.
- Product code
- Product code PPN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code PPN
view all- K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- K250225 — Bolt Intravascular Lithotripsy (IVL) System
- K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
- K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
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.