FDA 510(k) K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS

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.
Regulation Number: 880.5965
Classification Product Code: LJT  
Date Received: 05/27/2008
Decision Date: 09/23/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Type: Traditional

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