# K250225: Bolt Intravascular Lithotripsy (IVL) System

- Pathway: 510(k) (Traditional)
- Applicant: Bolt Medical, Inc.
- Decided: Mar 25, 2025 after 57 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: 14 generations back to K904788 (1990). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable, Shockwave Medical, Inc. (2016) Summary page 5.

## Most influential descendants
- K260246: SEISMIQ™ Intravascular Lithotripsy System (2026), 0 descendants of its own

## Indications for use
The Bolt Intravascular Lithotripsy (IVL) 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/K250225
Methodology: https://510kreport.com/methodology