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    FDA 510(k), K043465, 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

    FDA 510(k), K043465, 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

    $89.00 USD
    $89.00 USD
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    510(K) Number: K043465
    Device Name: 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
    Manufacturer:
    Device Classification Name: Catheter For Crossing Total Occlusions
    Regulation Number: 870.1250
    Classification Product Code: PDU
    Date Received: 12/15/2004
    Decision Date: 08/18/2005
    Regulation Medical Specialty: 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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