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    FDA 510(k), K202182, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

    FDA 510(k), K202182, ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

    $89.00 USD
    $89.00 USD
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    510(K) Number: K202182
    Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
    Manufacturer: Jake Wolenberg
    Device Classification Name: Catheter, Thrombus Retriever
    Regulation Number:    870.1250
    Classification Product Code:    NRY  
    Date Received    08/04/2020
    Decision Date    09/02/2020
    Decision    Substantially Equivalent (SESE)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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