FDA 510(k) Application Details - K232730

Device Classification Name

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510(K) Number K232730
Device Name Aventus Thrombectomy System
Applicant Inquis Medical
1755 East Bayshore Road, Suite 26
Redwood City, CA 94063 US
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Contact Mojgan Saadat
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Regulation Number

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Classification Product Code QEW
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Date Received 09/07/2023
Decision Date 11/01/2023
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

FDA Source Information for K232730


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