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510(k) K230706

EMBOLD™ Soft Detachable Coil System by Boston Scientific Corporation — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2023
Date Received
March 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

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