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.
Clearance details
- Applicant
- Bolt Medical, Inc.
- Product code
- 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.