FDA 510(k), K040139, ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER

FDA 510(k), K040139, ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER

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510(K) Number: K040139
Device Name: ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
Manufacturer: ENDOBIONICS, INC.
Device Classification Name: catheter, continuous flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 01/22/2004
Decision Date: 02/18/2004
Regulation Medical Specialty: Cardiovascular

Total pages: 299
Fully redacted pages: 177
Content pages: 122

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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