FDA 510(k), K162524, AZUR CX Detachable 18 Peripheral Coil System
FDA 510(k), K162524, AZUR CX Detachable 18 Peripheral Coil System
510(K) Number: K162524
Device Name: AZUR CX Detachable 18 Peripheral Coil System
Manufacturer: MicroVention, Inc
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 09/09/2016
Decision Date: 03/03/2017
Regulation Medical Specialty: Cardiovascular
Total pages: 2,131
Fully redacted pages: 1,030
Content pages: 1,101
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details