EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..


Device Classification Name

temporary carotid catheter for embolic capture

510(k) Number K110909
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
Applicant
ABBOTT LABORATORIES
3200 lakeside drive
santa clara, 
CA 
95054

Applicant Contact cherece l jones
Correspondent
ABBOTT LABORATORIES
3200 lakeside drive
santa clara, 
CA 
95054

Correspodent Contact cherece l jones
Regulation Number 870.1250
Classification Product Code
NTE  
Date Received 03/31/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Clinical Trials NCT00402740
Reviewed by Third Party No

Combination Product

No