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FDA 510(k) Application Details - K113266
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K113266
Device Name
Device, Vascular, For Promoting Embolization
Applicant
VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis, MN 55369 US
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Contact
JENNIFER RUETHER
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/04/2011
Decision Date
05/14/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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