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 14 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 |
|---|---|---|---|
| K260246 | Bolt Medical | SEISMIQ Intravascular Lithotripsy System | Aug 24, 2026 |
| K262201 | Shockwave Medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera | Jul 27, 2026 |
| K250225 | Bolt Medical | Bolt Intravascular Lithotripsy (IVL) System | Mar 25, 2025 |
| K242213 | Shockwave Medical | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Int | Sep 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 | Mar 22, 2024 |
| K221852 | Shockwave Medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera | Aug 16, 2022 |
| K221041 | Shockwave Medical | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Apr 25, 2022 |
| K203365 | Shockwave Medical | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripher | Apr 22, 2021 |
| K191840 | Shockwave Medical | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connecto | Aug 7, 2019 |
| K180958 | Shockwave Medical | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular | Jul 26, 2018 |
| K180454 | Shockwave Medical | Shockwave Medical Intravascular Lithotripsy (IVL) System | Jun 27, 2018 |
| K163306 | Shockwave Medical | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Co | Dec 22, 2016 |
| K161384 | Shockwave Medical | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Co | Sep 14, 2016 |