ARTERIA OCCLUSION BALLOON


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K021210
Device Name ARTERIA OCCLUSION BALLOON
Original Applicant
ARTERIA MEDICAL SCIENCE, INC.
22 hill st.
newburyport, 
MA 
01950

Original Contact alan hinton
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 04/17/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No