BEUDAMED
    3 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Terminated × Clear all

    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.

    FDA Enforcement
    Class I ·Terminated·Abbott Vascular·March 16, 2016

    Regard Dressing change kit, Item Number 800026006

    FDA Enforcement
    Class I ·Terminated·ROi CPS LLC·January 10, 2024

    regard Operative LAP, Item Number 800943001; surgical convenience kit

    FDA Enforcement
    Class I ·Terminated·ROi CPS LLC·January 24, 2024