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FDA 510(k) Application Details - K231954
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
More FDA Info for this Device
510(K) Number
K231954
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
Scientia Vascular, Inc.
2460 S 3270 W
West Valley City, UT 84119 US
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Contact
Bailey Johannsen
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
MOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2023
Decision Date
08/01/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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