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FDA 510(k) Application Details - K230743
Device Classification Name
More FDA Info for this Device
510(K) Number
K230743
Device Name
ICHOR 14F Embolectomy System
Applicant
ICHOR
1900 NW 25th St.
Boca Raton, FL 33431 US
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Contact
Angela Mallery
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Regulation Number
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Classification Product Code
QEW
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More FDA Info for this Product Code
Date Received
03/16/2023
Decision Date
09/05/2023
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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