ARTERIA BLOOD FILTER


Device Classification Name

filter, infusion line

510(k) Number K021293
Device Name ARTERIA BLOOD FILTER
Original Applicant
ARTERIA MEDICAL SCIENCE, INC.
22 hill st.
newburyport, 
MA 
01950

Original Contact alan hinton
Regulation Number 880.5440
Classification Product Code
FPB  
Subsequent Product Code
BRZ  
Date Received 04/23/2002
Decision Date 08/22/2002
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