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    FDA 510(k), K233407, AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

    FDA 510(k), K233407, AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

    $89.00 USD
    $89.00 USD
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    Device Classification Name: Left Atrial Appendage Clip, Implantable
    510(k) Number: K233407
    Device Name: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
    Applicant: AtriCure, Inc.
    Regulation Number: 878.4300
    Classification Product Code: PZX
    Subsequent Product Code: FZX
    Date Received: 10/05/2023
    Decision Date: 11/02/2023
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: General & Plastic Surgery
    510k Review Panel: Cardiovascular

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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