FDA 510(K), K140796 MEDUSA VASCULAR PLUG

FDA 510(K), K140796 MEDUSA VASCULAR PLUG

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Device Classification Name    Device, Vascular, For Promoting Embolization
510(k) Number    K140796
Device Name    MEDUSA VASCULAR PLUG,
Applicant    ENDOSHAPE, INC.
Regulation Number    870.3300
Classification Product Code    KRD  
Date Received    03/31/2014
Decision Date    12/02/2014
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Cardiovascular

Total pages: 178  
Fully redacted pages: 74  
Content pages: 104 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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