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FDA 510(k) Application Details - K182337
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
More FDA Info for this Device
510(K) Number
K182337
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
Balt USA, LLC
29 Parker
Irvine, CA 92618 US
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Contact
Nancy Xu
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
MOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2018
Decision Date
10/04/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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