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FDA 510(k) Application Details - K242557
Device Classification Name
More FDA Info for this Device
510(K) Number
K242557
Device Name
ClotTriever XL Catheter (41-102)
Applicant
Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine, CA 92618 US
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Contact
Kaitlyn Weinkauf
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QEW
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More FDA Info for this Product Code
Date Received
08/28/2024
Decision Date
09/27/2024
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
FDA Source Information for K242557
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