510(k) K221852
- Device
- Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 Peripheral IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- 510(k) number
- K221852
- Product code
- PPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-16
- Date received
- 2022-06-27
- Regulation
- 870.1250
- Classification name
- Percutaneous Catheter, Ultrasound
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Danica Van
- Address
- 5403 Betsy Ross Dr. Santa Clara CA US 95054 95054
FDA Registration Numbers#
- 3041000776
- 3007738736
- 3004363082
- 3027545377
- 3009018440
- 2030598
- 3010273872
- 2030624
- 2124215
- 3012102437
- 3010086866
- 3015053858
Source Documents#
Other 510(k) Records For Product Code PPN #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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