# K221041: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

- Pathway: 510(k) (Special)
- Applicant: Shockwave Medical, Inc.
- Decided: Apr 25, 2022 after 17 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: 17 generations back to K904788 (1990). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203365: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter, Shockwave Medical, Inc. (2021) Summary page 4.

## Indications for use
The Shockwave Medical 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/K221041
Methodology: https://510kreport.com/methodology