FDA 510(k) Applications for Medical Device Product Code: PPN ()

FDA 510(k) Applications for Medical Device Product Code "PPN"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K250225	Bolt Medical, Inc.	Bolt Intravascular Lithotripsy (IVL) System	03/25/2025
K161384	Shockwave Medical, Inc.	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable	09/14/2016
K163306	Shockwave Medical, Inc.	Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable	12/22/2016
K191840	Shockwave Medical, Inc.	Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)	08/07/2019
K242213	Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter	09/27/2024
K240225	Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter	03/22/2024
K221852	Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	08/16/2022
K240954	Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	05/07/2024
K203365	Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter	04/22/2021
K180958	Shockwave Medical, Inc.	Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable	07/26/2018
K180454	Shockwave Medical, Inc.	Shockwave Medical Intravascular Lithotripsy (IVL) System	06/27/2018
K221041	Shockwave Medical, Inc.	Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System	04/25/2022