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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K072375
Device Name SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
Applicant
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received08/23/2007
Decision Date 12/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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