BEUDAMED
    2 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.

    FDA Enforcement
    Class I ·Ongoing·Biosense Webster, Inc.·March 12, 2025

    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

    FDA Enforcement
    Class I ·Terminated·Biosense Webster, Inc.·September 5, 2018