Shockwave Medical, Inc.
Dispositifs autorisés FDA 510(k) et PMA — 13 produits
Publicité
Nombre total de dispositifs13
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2026-07-27 | Voir |
| 510(k) | K243757 | Shockwave CS Guide Catheter | DQY | 2025-05-02 | Voir |
| 510(k) | K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | PPN | 2024-09-27 | Voir |
| 510(k) | K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2024-05-07 | Voir |
| 510(k) | K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | PPN | 2024-03-22 | Voir |
| 510(k) | K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | PPN | 2022-08-16 | Voir |
| 510(k) | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | PPN | 2022-04-25 | Voir |
| 510(k) | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | PPN | 2021-04-22 | Voir |
| 510(k) | K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | PPN | 2019-08-07 | Voir |
| 510(k) | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | PPN | 2018-07-26 | Voir |
| 510(k) | K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | PPN | 2018-06-27 | Voir |
| 510(k) | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | PPN | 2016-12-22 | Voir |
| 510(k) | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | PPN | 2016-09-14 | Voir |
Aucun dispositif correspondant.