# K191840: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

- Pathway: 510(k) (Special)
- Applicant: Shockwave Medical, Inc.
- Decided: Aug 7, 2019 after 29 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: 16 generations back to K904788 (1990). 73 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180454: Shockwave Medical Intravascular Lithotripsy (IVL) System, Shockwave Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (2024), 1 descendant of its own
- K262201: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (2026), 0 descendants of its own
- K242213: Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (2024), 0 descendants of its own

## Indications for use
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K191840
Methodology: https://510kreport.com/methodology