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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K081472
Device Name SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/27/2008
Decision Date 09/23/2008
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
Recalls CDRH Recalls
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