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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K252509
Device Name AlphaVac Multipurpose Mechanical Aspiration System F1885
Applicant
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Applicant Contact Kasey Newcomb
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact Kasey Newcomb
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received08/08/2025
Decision Date 11/24/2025
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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