FDA 510(k), K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION

FDA 510(k), K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION

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510(K) Number: K000881
Device Name: PERFADEX SOLUTION FOR ORGAN PRESERVATION
Manufacturer:
Device Classification Name: System And Accessories, Isolated Heart, Transport And Preservation
Regulation Number: 876.5880
Classification Product Code: MSB
Date Received: 03/20/2000
Decision Date: 03/08/2001
Regulation Medical Specialty: Gastroenterology/Urology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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