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FDA 510(k) Application Details - K223560
Device Classification Name
More FDA Info for this Device
510(K) Number
K223560
Device Name
Plato 17 Microcatheter
Applicant
Scientia Vascular Inc
3487 West 2100 South Suite 100
West Valley City, UT 84119 US
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Contact
Max Alfonso
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Regulation Number
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Classification Product Code
QJP
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Date Received
11/28/2022
Decision Date
08/21/2023
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
N
Expedited Review
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