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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K263076
Device Name AngioVac F1885
Applicant
AngioDynamics, Inc.
603 Queensbury Ave.
Queensbury,  NY  12804
Applicant Contact Sameer Mansour
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensbury,  NY  12804
Correspondent Contact Sameer Mansour
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/01/2026
Decision Date 10/30/2026
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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