Bolt Intravascular Lithotripsy (IVL) System
FDA 510(k) K250225 · Bolt Medical, Inc.
510(k) numberK250225
Submission
- Device name
- Bolt Intravascular Lithotripsy (IVL) System
- Applicant
- Bolt Medical, Inc.
Carlsbad, CA, US - Received
- January 27, 2025
- Decision date
- March 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Special | Shockwave Medical, Inc. | 07/27/2026SE |
| 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 |
|---|---|---|
| K260246 | SEISMIQ Intravascular Lithotripsy SystemPPN · Traditional | 08/24/2026SE |
Questions and answers
When was Bolt Intravascular Lithotripsy (IVL) System cleared by the FDA?
Bolt Intravascular Lithotripsy (IVL) System (K250225) received a 510(k) decision of Substantially Equivalent on March 25, 2025, 57 days after the submission was received.
What is the product code of K250225?
The FDA product code is PPN – Percutaneous Catheter, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 870.1250.