Panels › Cardiovascular › Product code PPN · Class 2
Percutaneous Catheter, Ultrasound
Regulation 870.1250
2510(k)s in 12 months (14 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PPN
| Company | 510(k)s | Recalls |
|---|---|---|
| Shockwave Medical, Inc. | 12 | 1 |
| Bolt Medical, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K260246 | SEISMIQ Intravascular Lithotripsy System Bolt Medical, Inc. | PPN |
| Jul 27, 2026 | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Mar 25, 2025 | K250225 | Bolt Intravascular Lithotripsy (IVL) System Bolt Medical, Inc. | PPN |
| Sep 27, 2024 | K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave Medical, Inc. | PPN |
| May 7, 2024 | K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Mar 22, 2024 | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Aug 16, 2022 | K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Apr 25, 2022 | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. | PPN |
| Apr 22, 2021 | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Aug 7, 2019 | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replac Shockwave Medical, Inc. | PPN |
| Jul 26, 2018 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connecto Shockwave Medical, Inc. | PPN |
| Jun 27, 2018 | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. | PPN |
| Dec 22, 2016 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cab Shockwave Medical, Inc. | PPN |
| Sep 14, 2016 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cab Shockwave Medical, Inc. | PPN |
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