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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K192864
Device Name UNI*FUSE Infusion System with Cooper Wire
Applicant
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact Brandon M. Brackett
Correspondent
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact Brandon M. Brackett
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received10/07/2019
Decision Date 06/01/2020
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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