FDA 510(k)

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

N.º K: K240225 · 2024-03-22

Fecha de decisión2024-03-22

Código de productoPPN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K240225. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K240225.

When did Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter receive FDA 510(k) clearance?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter received FDA 510(k) clearance on 2024-03-22, under 510(k) number K240225.

Who is the listed applicant for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

The FDA 510(k) record lists Shockwave Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

The FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is PPN.

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Otros registros que enlistan a Shockwave Medical, Inc. como solicitante

K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter K243757Shockwave CS Guide Catheter K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: PPN)

K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.

Fuente oficial

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