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    FDA 510(k), K032041, DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

    FDA 510(k), K032041, DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

    $302.84 USD
    $302.84 USD
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    Device Classification Name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
    510(k) Number: K032041
    Device Name: DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
    Applicant: LEMAITRE VASCULAR, INC.
    Regulation Number: 870.4210
    Classification Product Code: DWF  
    Date Received: 07/01/2003
    Decision Date: 08/27/2003
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Cardiovascular
    510k Review Panel: Cardiovascular
    Type: Traditional

    101 pages (57 of 158 original pages are fully redacted)

    Contents: 510K Summary, Correspondence, Indications for Use, Substantial Equivalence Table, Directions for Use, CDRH Submission Cover Sheet, 510(k) Notification

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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