GORE EMBOLIC FILTER


Device Classification Name

temporary carotid catheter for embolic capture

510(k) Number K103500
Device Name GORE EMBOLIC FILTER
Applicant
W.L. GORE & ASSOCIATES,INC
4250 west kiltie lane
flagstaff, 
AZ 
86001

Applicant Contact michelle a wells
Correspondent
W.L. GORE & ASSOCIATES,INC
4250 west kiltie lane
flagstaff, 
AZ 
86001

Correspodent Contact michelle a wells
Regulation Number 870.1250
Classification Product Code
NTE  
Date Received 11/29/2010
Decision Date 05/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No