SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET


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.
queensbury, 
NY 
12804

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

Correspodent Contact brian kunst
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
LJT  
Date Received 08/23/2007
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