FDA.reportPublic FDA data

Ultrasonic lithotripsy system transducer, single-use

Definition
A catheter-enclosed device used as a component of an ultrasonic lithotripsy system to transform electrical energy into ultrasonic energy to deliver localized lithotripsy treatments (the breaking up of a stone or calculus). It is introduced into the body through vascular access, surgically, or endoscopically. This ultrasound transducer is composed of either a single transducer element or an array of transducer elements [i.e., piezoelectric or active element(s), or crystal(s) and associated damping, backing, and matching layer materials]. This is a single-use device.
GUDID devices
14
Last updated
2022-11-01 08:20:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.L6IVL0800302022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.L6IVL0900302022-10-24
00195451000409Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.L6IVL1000302022-10-24
00195451000416Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.L6IVL1200302022-10-24
00195451000317Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.S4IVLK25402021-06-08
00195451000324Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.S4IVLK30402021-06-08
00195451000331Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.S4IVLK35402021-06-08
00195451000348Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.S4IVLK40402021-06-08
00195451000089Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc.C2IVL25122021-02-17
00195451000096Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter Shockwave Medical, Inc.C2IVL30122021-02-17
00195451000102Shockwave IVL System with the Shockwave C2 Coronary IVL CatheterShockwave Medical, Inc.C2IVL35122021-02-17
00195451000119Shockwave IVL System with the Shockwave C2 Coronary IVL CatheterShockwave Medical, Inc.C2IVL40122021-02-17
00195451000294Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.IVLGCCD2021-02-11
00195451000300Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.IVLCC2021-02-11