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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K260091
Device Name Aventus Introducer Sheath
Applicant
Inquis Medical
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Applicant Contact Zachary Woodson
Correspondent
Inquis Medical
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Correspondent Contact Zachary Woodson
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/12/2026
Decision Date 04/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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