PPN · Class II · 21 CFR 870.1250

FDA Product Code PPN: Percutaneous Catheter, Ultrasound

Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature.

Leading manufacturers include Shockwave Medical, Inc. and Bolt Medical, Inc..

13
Total
13
Cleared
66d
Avg days
2016
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 48d recently vs 72d historically

FDA 510(k) Cleared Percutaneous Catheter, Ultrasound Devices (Product Code PPN)

13 devices
1–13 of 13
Cleared Mar 25, 2025
Bolt Intravascular Lithotripsy (IVL) System
K250225
Bolt Medical, Inc.
Cardiovascular · 57d
Cleared Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
K242213
Shockwave Medical, Inc.
Cardiovascular · 60d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
K240954
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
K240225
Shockwave Medical, Inc.
Cardiovascular · 56d
Cleared Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
K221852
Shockwave Medical, Inc.
Cardiovascular · 50d
Cleared Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041
Shockwave Medical, Inc.
Cardiovascular · 17d
Cleared Apr 22, 2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
K203365
Shockwave Medical, Inc.
Cardiovascular · 157d
Cleared Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
K191840
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
K180958
Shockwave Medical, Inc.
Cardiovascular · 105d
Cleared Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
K180454
Shockwave Medical, Inc.
Cardiovascular · 127d

About Product Code PPN - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code PPN since 2016, with 13 receiving FDA clearance (average review time: 66 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PPN Product Code

Recent submissions under PPN have taken an average of 48 days to reach a decision - down from 72 days historically, suggesting improved FDA processing for this classification.

PPN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →