FDA 510(k) Applications for Medical Device Product Code "PPN"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
| K221852 | Shockwave Medical, Inc. | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | 08/16/2022 |
| 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 |
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