# K262201: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

- Pathway: 510(k) (Special)
- Applicant: Shockwave Medical, Inc.
- Decided: Jul 27, 2026 after 28 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: 18 generations back to K904788 (1990). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter, Shockwave Medical, Inc. (2024) Summary page 5.

## 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, carotid or cerebral vasculature.

Source page: https://510kreport.com/device/K262201
Methodology: https://510kreport.com/methodology