GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET


Device Classification Name

set, administration, intravascular

510(k) Number K030467
Device Name GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
Applicant
IV MEDICAL, INC.
7854 sitio coco
carlsbad, 
CA 
92009

Applicant Contact michael g simon
Correspondent
IV MEDICAL, INC.
7854 sitio coco
carlsbad, 
CA 
92009

Correspodent Contact michael g simon
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 02/12/2003
Decision Date 03/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No