FDA 510(k), K090168, AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

FDA 510(k), K090168, AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

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510(K) Number: K090168
Device Name: AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
Manufacturer: MICROVENTION, INC.
Device Classification Name: device, neurovascular embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 01/23/2009
Decision Date: 03/12/2009
Regulation Medical Specialty: Neurology

Total pages: 138
Fully redacted pages: 68
Content pages: 70

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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