# Shockwave Medical, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 14 (2016–2026): 13 510(k) clearances and 1 original PMA approval
- Product codes: PPN (12), QMG (1), DQY (1)
- 510(k) review time since 2016: median 58 days, against 56 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 15 (11 its own); citations of its devices by later devices: 12 (11 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Angioscore, Inc.: 1 (https://510kreport.com/company/angioscore)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Ekos Corp.: 1 (https://510kreport.com/company/ekos)

## Firms that cite its devices most
- Bolt Medical, Inc.: 1 (https://510kreport.com/company/bolt-medical)

## Its most-cited devices
- 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
- 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

## Recent decisions
- K262201: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (Jul 27, 2026)
- K243757: Shockwave CS Guide Catheter (May 2, 2025)
- K242213: Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (Sep 27, 2024)
- K240954: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (May 7, 2024)
- K240225: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (Mar 22, 2024)
- K221852: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (Aug 16, 2022)
- K221041: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (Apr 25, 2022)
- K203365: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (Apr 22, 2021)

Source page: https://510kreport.com/company/shockwave-medical