FDA 510(k) K213398, EMBOLD Fibered Detachable Coil System, by Boston Scientific Corporation

FDA 510(k) K213398, EMBOLD Fibered Detachable Coil System, by Boston Scientific Corporation

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Device Classification Name: Device, Vascular, For Promoting Embolization
510(k) Number: K213398
Device Name: EMBOLD Fibered Detachable Coil System
Applicant: Boston Scientific Corporation
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 10/18/2021
Decision Date: 04/12/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular

Total number of pages: 3,645
Fully redacted pages: 3,138
Content pages: 507

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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