EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM


Device Classification Name

temporary carotid catheter for embolic capture

510(k) Number K081523
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Applicant
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Applicant Contact danielle taylor
Correspondent
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Correspodent Contact danielle taylor
Regulation Number 870.1250
Classification Product Code
NTE  
Date Received 06/02/2008
Decision Date 09/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No