# PPN: Percutaneous Catheter, Ultrasound

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 56 days (middle half 40–59)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2018: 2
- 2019: 1
- 2021: 1
- 2022: 2
- 2024: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K191840: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (2019), cited by 2
- K163306: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (2016), cited by 2
- K180958: Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (2018), cited by 2
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), cited by 2
- K250225: Bolt Intravascular Lithotripsy (IVL) System (2025), cited by 1
- K180454: Shockwave Medical Intravascular Lithotripsy (IVL) System (2018), cited by 1
- K221852: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (2022), cited by 1
- K203365: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (2021), cited by 1
- K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (2024), cited by 1

Source page: https://510kreport.com/product-code/PPN
Data by year (CSV): https://510kreport.com/product-code/PPN.csv