Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
FDA 510(k) K180958 · Shockwave Medical, Inc.
510(k) numberK180958
Submission
- Device name
- Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
- Applicant
- Shockwave Medical, Inc.
Fremont, CA, US - Received
- April 12, 2018
- Decision date
- July 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPN – Percutaneous Catheter, Ultrasound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Other 510(k)s with product code PPN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260246 | SEISMIQ Intravascular Lithotripsy SystemPPN · Traditional | Bolt Medical, Inc. | 08/24/2026SE |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Special | Shockwave Medical, Inc. | 07/27/2026SE |
| K250225 | Bolt Intravascular Lithotripsy (IVL) SystemPPN · Traditional | Bolt Medical, Inc. | 03/25/2025SE |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…PPN · Traditional | Shockwave Medical, Inc. | 09/27/2024SE |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Special | Shockwave Medical, Inc. | 05/07/2024SE |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 03/22/2024SE |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 08/16/2022SE |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPN · Special | Shockwave Medical, Inc. | 04/25/2022SE |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…PPN · Traditional | Shockwave Medical, Inc. | 04/22/2021SE |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…PPN · Special | Shockwave Medical, Inc. | 08/07/2019SE |
More from Shockwave Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Special | 07/27/2026SE |
| K243757 | Shockwave CS Guide CatheterDQY · Traditional | 05/02/2025SE |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…PPN · Traditional | 09/27/2024SE |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Special | 05/07/2024SE |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Traditional | 03/22/2024SE |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…PPN · Traditional | 08/16/2022SE |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPN · Special | 04/25/2022SE |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…PPN · Traditional | 04/22/2021SE |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…PPN · Special | 08/07/2019SE |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) SystemPPN · Traditional | 06/27/2018SE |
Questions and answers
When was Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable cleared by the FDA?
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (K180958) received a 510(k) decision of Substantially Equivalent on July 26, 2018, 105 days after the submission was received.
What is the product code of K180958?
The FDA product code is PPN – Percutaneous Catheter, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 870.1250.