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.
603 queensbury ave.
queensbury, 
NY 
12804

Applicant Contact brian kunst
Correspondent
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Correspodent Contact brian kunst
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

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls