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    FDA 510(k) K022357, TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815, by Boston Scientific, Target

    FDA 510(k) K022357, TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815, by Boston Scientific, Target

    $826.30 USD
    $826.30 USD
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    Device Classification Name: Wire, Guide, Catheter
    510(k) Number: K022357
    Device Name: TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
    Applicant: Boston Scientific, Target
    Regulation Number: 870.1330
    Classification Product Code: DQX
    Date Received: 07/19/2002
    Decision Date: 10/16/2002
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Cardiovascular
    510k Review Panel: Cardiovascular

    Total number of pages: 270
    Fully redacted pages: 0
    Content pages: 270

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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