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FDA 510(k) Application Details - K181647
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K181647
Device Name
Wire, Guide, Catheter
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis, MN 55369 US
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Contact
Becky Astrup
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2018
Decision Date
07/20/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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