FDA 510(k) Application Details - K250202

Device Classification Name

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510(K) Number K250202
Device Name Aventus Thrombectomy System
Applicant Inquis Medical
1530 O'Brien Drive
Suite A
Menlo Park, CA 94025 US
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Contact Zachary Woodson
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Regulation Number

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Classification Product Code QEW
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Date Received 01/24/2025
Decision Date 02/26/2025
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 K250202


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