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Shockwave Medical, Inc.

FDA 510(k) & PMA Approved Dispositivos — 13 products

Total de dispositivos13
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K262201 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPN2026-07-27 Ver
510(k) K243757 Shockwave CS Guide CatheterDQY2025-05-02 Ver
510(k) K242213 Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterPPN2024-09-27 Ver
510(k) K240954 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterPPN2024-05-07 Ver
510(k) K240225 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPN2024-03-22 Ver
510(k) K221852 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterPPN2022-08-16 Ver
510(k) K221041 Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemPPN2022-04-25 Ver
510(k) K203365 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL CatheterPPN2021-04-22 Ver
510(k) K191840 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)PPN2019-08-07 Ver
510(k) K180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector CablePPN2018-07-26 Ver
510(k) K180454 Shockwave Medical Intravascular Lithotripsy (IVL) SystemPPN2018-06-27 Ver
510(k) K163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector CablePPN2016-12-22 Ver
510(k) K161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CablePPN2016-09-14 Ver
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