FDA 510(k) Application Details - K250088

Device Classification Name

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510(K) Number K250088
Device Name FlowTriever2 Catheter
Applicant Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine, CA 92618 US
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Contact Rayee Patil
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Regulation Number

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Classification Product Code QEW
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Date Received 01/14/2025
Decision Date 03/13/2025
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

FDA Source Information for K250088


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