# K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

- Pathway: 510(k) (Traditional)
- Applicant: Shockwave Medical, Inc.
- Decided: Sep 14, 2016 after 118 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: 13 generations back to K904788 (1990). 70 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating, Angioscore, Inc. (2015) Summary page 4.
- K103459: Vascutrak Pta Dilatation Catheter, C.R. Bard, Inc. (2010) Summary page 4.
- K060422: Lysus Infusion System, Ekos Corp. (2006) Summary page 4.

## Most influential descendants
- K163306: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (2016), 10 descendants of its own
- K180958: Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (2018), 4 descendants of its own
- K180454: Shockwave Medical Intravascular Lithotripsy (IVL) System (2018), 4 descendants of its own
- K191840: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (2019), 3 descendants of its own
- K250225: Bolt Intravascular Lithotripsy (IVL) System (2025), 1 descendant of its own

## Indications for use
The Shockwave Medical Lithoplasty 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/K161384
Methodology: https://510kreport.com/methodology