Product code QMG
- Device name
- Shockwave Intravascular Lithotripsy System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Dilatation of coronary arteries prior to stenting
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P200039S022 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter; Sh | Shockwave Medical, Inc. | 2026-05-07 |
| P200039S020 | Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2026-03-05 |
| P200039S019 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat | Shockwave Medical, Inc. | 2026-02-20 |
| P200039S018 | Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2025-10-14 |
| P200039S017 | Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators | Shockwave Medical, Inc. | 2025-06-27 |
| P200039S015 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete | Shockwave Medical, Inc. | 2025-06-10 |
| P200039S016 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2025-05-30 |
| P200039S013 | Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter | Shockwave Medical, Inc. | 2024-10-24 |
| P200039S014 | Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2024-03-26 |
| P200039S005 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2023-08-17 |
| P200039S012 | Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r | Shockwave Medical, Inc. | 2023-06-15 |
| P200039S011 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2023-05-08 |
| P200039S010 | Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters | Shockwave Medical, Inc. | 2023-03-22 |
| P200039S009 | Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac | Shockwave Medical, Inc. | 2023-02-02 |
| P200039S008 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2022-12-13 |
| P200039S007 | Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 | Shockwave Medical, Inc. | 2022-09-01 |
| P200039S006 | Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter | Shockwave Medical, Inc. | 2022-03-23 |
| P200039S004 | Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | 2022-01-04 |
| P200039S003 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter | Shockwave Medical, Inc. | 2021-07-22 |
| P200039S002 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2021-06-04 |
| P200039S001 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2021-04-09 |
| P200039 | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | 2021-02-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195451001154 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | Shockwave Medical, Inc. | 2026-05-14 |
| 00195451001147 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | Shockwave Medical, Inc. | 2026-05-14 |
| 00195451001130 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | Shockwave Medical, Inc. | 2026-05-14 |
| 00195451001123 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | Shockwave Medical, Inc. | 2026-05-14 |
| 00195451000621 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2025-07-10 |
| 00195451000614 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2025-07-10 |
| 00195451000607 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2025-07-10 |
| 00195451000591 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | Shockwave Medical, Inc. | 2025-07-10 |
| 00195451000010 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | Shockwave Medical, Inc. | 2023-08-16 |
| 00195451000034 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | Shockwave Medical, Inc. | 2023-08-16 |
| 00195451000027 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | Shockwave Medical, Inc. | 2023-08-16 |
| 00195451000003 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | Shockwave Medical, Inc. | 2023-08-16 |
| 00195451000355 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2022-12-22 |
| 00195451000089 | Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter | Shockwave Medical, Inc. | 2021-02-17 |
| 00195451000096 | Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter | Shockwave Medical, Inc. | 2021-02-17 |
| 00195451000102 | Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter | Shockwave Medical, Inc. | 2021-02-17 |
| 00195451000119 | Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter | Shockwave Medical, Inc. | 2021-02-17 |
| 00195451000300 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2021-02-11 |
| 00195451000294 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2021-02-11 |
| M732IVLGCCD0 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2019-06-17 |
| M732IVLGCC0 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2018-12-14 |
| M732IVLCC0 | Shockwave Medical IVL Generator and Connector Cable | Shockwave Medical, Inc. | 2018-12-14 |
| M732LCC825D1 | Lithoplasty® | Shockwave Medical, Inc. | 2017-03-09 |