# K260246: SEISMIQ™ Intravascular Lithotripsy System

- Pathway: 510(k) (Traditional)
- Applicant: Bolt Medical, Inc.
- Decided: Aug 24, 2026 after 209 days
- Product code: PPN (Percutaneous Catheter, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K904788 (1990). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250225: Bolt Intravascular Lithotripsy (IVL) System, Bolt Medical, Inc. (2025) Summary page 5.

## Indications for use
The SEISMIGMVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid or cerebral vasculature.

Source page: https://510kreport.com/device/K260246
Methodology: https://510kreport.com/methodology