Shockwave Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Shockwave Medical, Inc.” (first 2016, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 56 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 74 |
| 2017 | 0 | — |
| 2018 | 2 | 116 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 1 | 157 |
| 2022 | 2 | 34 |
| 2023 | 0 | — |
| 2024 | 3 | 56 |
| 2025 | 1 | 147 |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shockwave Medical, Inc. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PPN | Percutaneous Catheter, Ultrasound | 12 | 12 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| QMG | Shockwave Intravascular Lithotripsy System | 1 | 0 |
Review panels
- Cardiovascular (14)
Most recent Shockwave Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2026-07-27 | 28 |
| K243757 | Shockwave CS Guide Catheter | DQY | 2025-05-02 | 147 |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | PPN | 2024-09-27 | 60 |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2024-05-07 | 29 |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2024-03-22 | 56 |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2022-08-16 | 50 |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | PPN | 2022-04-25 | 17 |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | PPN | 2021-04-22 | 157 |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | PPN | 2019-08-07 | 29 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | PPN | 2018-07-26 | 105 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200039 | PMA | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | 2021-02-12 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-07-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Shockwave Medical, Inc. is the lead sponsor of 25 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT06662500: FORWARD CAD IDE Study (Recruiting, started 2025-04-04)
- NCT06938854: Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries (Active not recruiting, started 2025-03-10)
- NCT05966662: Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) (Completed, started 2023-12-08)
- NCT05858905: FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter (Completed, started 2023-06-27)
- NCT05755711: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (Active not recruiting, started 2023-05-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shockwave Medical, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Shockwave Medical, Inc.” (first 2016, latest 2026), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shockwave Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shockwave Medical, Inc. is 56 days. Since 2017: 56 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shockwave Medical, Inc.?
The most frequent FDA product codes under this applicant name are PPN (Percutaneous Catheter, Ultrasound, 12); DQY (Catheter, Percutaneous, 1); QMG (Shockwave Intravascular Lithotripsy System, 1).
Next steps
- See all 13 Shockwave Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PPN, Shockwave Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.