Product code PPN
- Device name
- Percutaneous Catheter, Ultrasound
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | 2025-03-25 |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2024-09-27 |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-05-07 |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-03-22 |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2022-08-16 |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2022-04-25 |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-04-22 |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | 2019-08-07 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. | 2018-07-26 |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2018-06-27 |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Shockwave Medical, Inc. | 2016-12-22 |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Shockwave Medical, Inc. | 2016-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850056723084 | SEISMIQ™ | Bolt Medical, Inc. | 2025-11-27 |
| 00850056723091 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723077 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723060 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723053 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723046 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723039 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723022 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723008 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00850056723015 | SEISMIQ™ | Bolt Medical, Inc. | 2025-10-31 |
| 00195451000799 | Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-10-09 |
| 00195451000577 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-04-17 |
| 00195451000560 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-04-17 |
| 00195451000553 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-04-17 |
| 00195451000546 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-04-17 |
| 00195451000539 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2024-04-17 |
| 00195451000348 | Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-06-08 |
| 00195451000331 | Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-06-08 |
| 00195451000324 | Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-06-08 |
| 00195451000317 | Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-06-08 |
| 00195451000287 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000270 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000263 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000256 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000249 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000232 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000225 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000218 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| 00195451000201 | Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | 2021-05-11 |
| M732LGCC825DX1 | Lithoplasty® | Shockwave Medical, Inc. | 2017-03-09 |