FDA product code PPN: Percutaneous Catheter, Ultrasound
PPN is the FDA product code for percutaneous catheter, ultrasound. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 14 510(k) submissions under PPN, 8 in the last five years, from 2 different applicants. The average 510(k) review took 76 days (median 56); 74 days on average over the last three years. FDA has posted 1 recall for PPN devices.
Definition
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Catheter, Ultrasound |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PPN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 116 |
| 2019 | 1 | 29 |
| 2021 | 1 | 157 |
| 2022 | 2 | 34 |
| 2024 | 3 | 48 |
| 2025 | 1 | 57 |
| 2026 | 2 | 118 |
Compare with all 510(k) review times · Search every PPN clearance
Top PPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shockwave Medical, Inc. | 12 | 2026-07-27 |
| Bolt Medical, Inc. | 2 | 2026-08-24 |
Most recent PPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260246 | Bolt Medical, Inc. | SEISMIQ Intravascular Lithotripsy System | 2026-08-24 | 209 |
| K262201 | Shockwave Medical, Inc. | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | 2026-07-27 | 28 |
| K250225 | Bolt Medical, Inc. | Bolt Intravascular Lithotripsy (IVL) System | 2025-03-25 | 57 |
| K242213 | Shockwave Medical, Inc. | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | 2024-09-27 | 60 |
| K240954 | Shockwave Medical, Inc. | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | 2024-05-07 | 29 |
Recalls for PPN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code PPN?
PPN is the FDA product code for percutaneous catheter, ultrasound. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is PPN?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code PPN?
Across 14 cleared submissions the average was 76 days from receipt to decision (median 56).
Which companies have the most PPN clearances?
Shockwave Medical, Inc. (12); Bolt Medical, Inc. (2).
Have PPN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code PPN
- Run a recall and safety report across every PPN manufacturer
- Watch product code PPN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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