Percutaneous Catheter, Ultrasound
Cardiovascular · 21 CFR 870.1250
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Recent MDR events
238 adverse event reports on file
- SEISMIQJul 21, 2026MalfunctionBolt Medical, Inc.2124215-2026-39437
- SEISMIQJul 16, 2026MalfunctionBolt Medical, Inc.2124215-2026-38340
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETERJul 10, 2026InjuryShockwave Medical, Inc.3015053858-2026-00075
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETERJul 9, 2026InjuryShockwave Medical, Inc.3015053858-2026-00074
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE E8 PERIPHERAL IVL CATHETERJul 8, 2026InjuryShockwave Medical, Inc.3015053858-2026-00073
- SEISMIQJul 2, 2026MalfunctionBolt Medical, Inc.2124215-2026-35630
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IVL CATHETERJun 29, 2026MalfunctionShockwave Medical, Inc.3015053858-2026-00066
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETERJun 29, 2026MalfunctionShockwave Medical, Inc.3015053858-2026-00065
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE L6 PERIPHERAL IVL CATHETERJun 26, 2026InjuryShockwave Medical, Inc.3015053858-2026-00067
- SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE M5+ PERIPHERAL IVL CATHETERJun 25, 2026InjuryShockwave Medical, Inc.3015053858-2026-00064
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
49 firms currently registered for this product code
Synergy Health Ast, Srl
Alajuela, CR
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Synergy Health Ast, Srl
Alajuela, CR
Shockwave Medical, Inc.
Santa Clara, CA, US
Vanguard-ems
BEAVERTON, OR, US
Isomedix Operations, Inc.
Temecula, CA, US
Synergy Health Ast, Llc
Petaluma, CA, US
Boston Scientific Corporation
Saint Paul, MN, US
510(k) clearances
13 clearances for this product code
- Shockwave Medical, Inc.Jul 27, 2026
K262201 · Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- Bolt Medical, Inc.Mar 25, 2025
K250225 · Bolt Intravascular Lithotripsy (IVL) System
- Shockwave Medical, Inc.Sep 27, 2024
K242213 · Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
- Shockwave Medical, Inc.May 7, 2024
K240954 · Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- Shockwave Medical, Inc.Mar 22, 2024
K240225 · Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
- Shockwave Medical, Inc.Aug 16, 2022
K221852 · Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- Shockwave Medical, Inc.Apr 25, 2022
K221041 · Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
- Shockwave Medical, Inc.Apr 22, 2021
K203365 · Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter