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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K171946
Device Name Gel-Bead
Applicant
Vascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis,  MN  55369
Applicant Contact Lisa Gallatin
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis,  MN  55369
Correspondent Contact Lisa Gallatin
Regulation Number870.3300
Classification Product Code
KRD  
Date Received06/29/2017
Decision Date 10/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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