FDA 510(k), K210544, Medtronic Extended infusion set

FDA 510(k), K210544, Medtronic Extended infusion set

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510(K) Number: K210544
Device Name: Medtronic Extended infusion set
Manufacturer: Unomedical A/S
Device Classification Name: set, administration, intravascular
Regulation Number: 880.5440
Classification Product Code: FPA
Date Received: 02/24/2021
Decision Date: 07/16/2021
Regulation Medical Specialty: General Hospital

Total pages: 163
Fully redacted pages: 10
Content pages: 153

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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