FDA 510(k), K062752, MERCATOR MICROSYRINGE II INFUSION CATHETER

FDA 510(k), K062752, MERCATOR MICROSYRINGE II INFUSION CATHETER

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510(K) Number: K062752
Device Name: MERCATOR MICROSYRINGE II INFUSION CATHETER
Manufacturer: MERCATOR MEDSYSTEMS, INC.
Device Classification Name: catheter, continuous flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 09/14/2006
Decision Date: 12/07/2006
Regulation Medical Specialty: Cardiovascular

Total pages: 306
Fully redacted pages: 170
Content pages: 136

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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