FIBERNET EMBOLIC PROTECTION DEVICE


Device Classification Name

temporary carotid catheter for embolic capture

510(k) Number K111987
Device Name FIBERNET EMBOLIC PROTECTION DEVICE
Applicant
LUMEN BIOMEDICAL, INC.
10900 73rd ave north
suite 150
maple grove, 
MN 
55369

Applicant Contact michelle straight
Correspondent
LUMEN BIOMEDICAL, INC.
10900 73rd ave north
suite 150
maple grove, 
MN 
55369

Correspodent Contact michelle straight
Regulation Number 870.1250
Classification Product Code
NTE  
Date Received 07/13/2011
Decision Date 08/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No