Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
FDA 510(k) K262201 · Shockwave Medical, Inc.
510(k) numberK262201
Submission
- Device name
- Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- Applicant
- Shockwave Medical, Inc.
Santa Clara, CA, US - Received
- June 29, 2026
- Decision date
- July 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPN – Percutaneous Catheter, Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Other 510(k)s with product code PPN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260246 | SEISMIQ Intravascular Lithotripsy SystemPPN · Traditional | Bolt Medical, Inc. | 08/24/2026SE |
| K250225 | Bolt Intravascular Lithotripsy (IVL) SystemPPN · Traditional | Bolt Medical, Inc. | 03/25/2025SE |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…PPN · Traditional | Shockwave Medical, Inc. | 09/27/2024SE |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Special | Shockwave Medical, Inc. | 05/07/2024SE |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 03/22/2024SE |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 08/16/2022SE |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPN · Special | Shockwave Medical, Inc. | 04/25/2022SE |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 04/22/2021SE |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…PPN · Special | Shockwave Medical, Inc. | 08/07/2019SE |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…PPN · Traditional | Shockwave Medical, Inc. | 07/26/2018SE |
More from Shockwave Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243757 | Shockwave CS Guide CatheterDQY · Traditional | 05/02/2025SE |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…PPN · Traditional | 09/27/2024SE |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Special | 05/07/2024SE |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Traditional | 03/22/2024SE |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Traditional | 08/16/2022SE |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPN · Special | 04/25/2022SE |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…PPN · Traditional | 04/22/2021SE |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…PPN · Special | 08/07/2019SE |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…PPN · Traditional | 07/26/2018SE |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) SystemPPN · Traditional | 06/27/2018SE |
Questions and answers
When was Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter cleared by the FDA?
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K262201) received a 510(k) decision of Substantially Equivalent on July 27, 2026, 28 days after the submission was received.
What is the product code of K262201?
The FDA product code is PPN – Percutaneous Catheter, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 870.1250.