AFX INTRODUCER SYSTEM


Device Classification Name

introducer, catheter

510(k) Number K110090
Device Name AFX INTRODUCER SYSTEM
Applicant
ENDOLOGIX, INC.
11 studebaker
irvine, 
CA 
92618

Applicant Contact janet m fauls
Correspondent
ENDOLOGIX, INC.
11 studebaker
irvine, 
CA 
92618

Correspodent Contact janet m fauls
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 01/12/2011
Decision Date 05/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No