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..
14
Total
14
Cleared
77d
Avg days
2016
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg
98d
recently vs 71d historically
FDA 510(k) Cleared Percutaneous Catheter, Ultrasound Devices (Product Code PPN)
14 devices
Cleared
Aug 24, 2026
SEISMIQ™ Intravascular Lithotripsy System
Bolt Medical, Inc.
Cardiovascular
209d
Cleared
Jul 27, 2026
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
Shockwave Medical, Inc.
Cardiovascular
28d
Cleared
Mar 25, 2025
Bolt Intravascular Lithotripsy (IVL) System
Bolt Medical, Inc.
Cardiovascular
57d
Cleared
Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter
Shockwave Medical, Inc.
Cardiovascular
60d
Cleared
May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Shockwave Medical, Inc.
Cardiovascular
29d
Cleared
Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
Shockwave Medical, Inc.
Cardiovascular
56d
Cleared
Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Shockwave Medical, Inc.
Cardiovascular
50d
Cleared
Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Shockwave Medical, Inc.
Cardiovascular
17d
Cleared
Apr 22, 2021
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
Shockwave Medical, Inc.
Cardiovascular
157d
Cleared
Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
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
Shockwave Medical, Inc.
Cardiovascular
105d
Cleared
Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
Shockwave Medical, Inc.
Cardiovascular
127d
Cleared
Dec 22, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter
Shockwave Medical, Inc.
Cardiovascular
29d
Cleared
Sep 14, 2016
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
Shockwave Medical, Inc.
Cardiovascular
118d
About Product Code PPN - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code PPN since 2016, with 14 receiving FDA clearance (average review time: 77 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA 510(k) Review Time - PPN Product Code
Recent submissions under PPN have taken an average of 98 days to reach a decision - up from 71 days historically. Manufacturers should account for longer review timelines in current project planning.
PPN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →