# K242213: Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shockwave Medical, Inc.
- Decided: Sep 27, 2024 after 60 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)
- K191840: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement), Shockwave Medical, Inc. (2019) Summary page 5.
- (no number) Shockwave S4 Peripheral IVL Catheter: named in the summary without a submission number

## Indications for use
The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, prior to final treatment. Not for use in the coronary, carotid, cerebral, or pulmonary vasculature.

Source page: https://510kreport.com/device/K242213
Methodology: https://510kreport.com/methodology