PPN — Percutaneous Catheter, Ultrasound Class II
FDA product code PPN covers "Percutaneous Catheter, Ultrasound", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PPN
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250225 | bolt medical | Bolt Intravascular Lithotripsy (IVL) System | March 25, 2025 |
| K242213 | shockwave medical | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Int | September 27, 2024 |
| K240954 | shockwave medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera | May 7, 2024 |
| K240225 | shockwave medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera | March 22, 2024 |
| K221852 | shockwave medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera | August 16, 2022 |
| K221041 | shockwave medical | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | April 25, 2022 |
| K203365 | shockwave medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripher | April 22, 2021 |
| K191840 | shockwave medical | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connecto | August 7, 2019 |
| K180958 | shockwave medical | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular | July 26, 2018 |
| K180454 | shockwave medical | Shockwave Medical Intravascular Lithotripsy (IVL) System | June 27, 2018 |
| K163306 | shockwave medical | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Co | December 22, 2016 |
| K161384 | shockwave medical | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Co | September 14, 2016 |