Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
FDA 510(k) K191840 · Shockwave Medical, Inc.
510(k) numberK191840
Submission
- Device name
- Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
- Applicant
- Shockwave Medical, Inc.
Santa Clara, CA, US - Received
- July 9, 2019
- Decision date
- August 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…PPN · Traditional | Shockwave Medical, Inc. | 07/26/2018SE |
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 |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…PPN · Traditional | 07/26/2018SE |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) SystemPPN · Traditional | 06/27/2018SE |
Questions and answers
When was Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) cleared by the FDA?
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (K191840) received a 510(k) decision of Substantially Equivalent on August 7, 2019, 29 days after the submission was received.
What is the product code of K191840?
The FDA product code is PPN – Percutaneous Catheter, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 870.1250.